0 Ratings
ID

43378

Description

ODM derived from http://clinicaltrials.gov/show/NCT00558584

Link

http://clinicaltrials.gov/show/NCT00558584

Keywords

Versions (3)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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Creative Commons BY 4.0
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    Eligibility NCT00558584 Dilated Cardiomyopathy

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age 18 Years to 65 Years
    Description

    age 18 Years to 65 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Dilated cardiomyopathy
    Description

    Dilated cardiomyopathy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0007193
    SNOMED CT 2011_0131
    195021004
    MedDRA 14.1
    10056419
    ICD-10-CM Version 2010
    I42.0
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    LVEF <= 40% determined by contrast echocardiography
    Description

    LVEF <= 40% determined by contrast echocardiography

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0428772
    SNOMED CT 2011_0131
    250908004
    MedDRA 14.1
    10069170
    UMLS CUI 2011AA
    C0521095
    SNOMED CT 2011_0131
    436000
    UMLS CUI 2011AA
    C0013518
    SNOMED CT 2011_0131
    433231002
    NYHA class II - IV
    Description

    NYHA class II - IV

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1319794
    SNOMED CT 2011_0131
    421704003
    MedDRA 14.1
    10064080
    UMLS CUI 2011AA
    C1319795
    SNOMED CT 2011_0131
    420913000
    MedDRA 14.1
    10064081
    UMLS CUI 2011AA
    C1319796
    SNOMED CT 2011_0131
    422293003
    MedDRA 14.1
    10064082
    Age 18 - 65
    Description

    Age 18 - 65

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Disease duration: symptomatic heart failure >1 year and <5 years prior to screening date
    Description

    Disease duration: symptomatic heart failure >1 year and <5 years prior to screening date

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0872146
    UMLS CUI 2011AA
    C0231220
    SNOMED CT 2011_0131
    264931009
    UMLS CUI 2011AA
    C0018801
    SNOMED CT 2011_0131
    155374007
    MedDRA 14.1
    10019279
    ICD-9-CM Version 2011
    428
    CTCAE 1105E
    E10124
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.
    Description

    Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0003015
    SNOMED CT 2011_0131
    372733002
    UMLS CUI 2011AA
    C0521942
    SNOMED CT 2011_0131
    372913009
    UMLS CUI 2011AA
    C0001645
    SNOMED CT 2011_0131
    33252009
    LOINC Version 232
    MTHU003324
    UMLS CUI 2011AA
    C0002007
    SNOMED CT 2011_0131
    372603003
    UMLS CUI 2011AA
    C1320929
    SNOMED CT 2011_0131
    405279007
    HL7 V3 2006_05
    ATTPHYS
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0205360
    SNOMED CT 2011_0131
    58158008
    LOINC Version 232
    MTHU015276
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    Informed Consent
    Description

    The patient's informed consent

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
    Description

    NYHA class IV patients who are bed-ridden and dependent upon parenteral medication

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1319796
    SNOMED CT 2011_0131
    422293003
    MedDRA 14.1
    10064082
    UMLS CUI 2011AA
    C0425251
    SNOMED CT 2011_0131
    160685001
    LOINC Version 232
    MTHU008262
    UMLS CUI 2011AA
    CL414916
    UMLS CUI 2011AA
    C1518896
    UMLS CUI 2011AA
    C0013227
    Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, >= 50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects >second degree
    Description

    Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, >= 50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects >second degree

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0018801
    SNOMED CT 2011_0131
    155374007
    MedDRA 14.1
    10019279
    ICD-9-CM Version 2011
    428
    CTCAE 1105E
    E10124
    UMLS CUI 2011AA
    C1274040
    SNOMED CT 2011_0131
    79409006
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0010068
    SNOMED CT 2011_0131
    53741008
    MedDRA 14.1
    10068617
    UMLS CUI 2011AA
    C0679403
    MedDRA 14.1
    10057469
    UMLS CUI 2011AA
    C0085532
    SNOMED CT 2011_0131
    33367005
    MedDRA 14.1
    10003200
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    UMLS CUI 2011AA
    C0152105
    SNOMED CT 2011_0131
    64715009
    MedDRA 14.1
    10020823
    ICD-10-CM Version 2010
    I11
    ICD-9-CM Version 2011
    402
    UMLS CUI 2011AA
    C2748945
    UMLS CUI 2011AA
    C0449286
    SNOMED CT 2011_0131
    246173007
    History of - myocardial infarction
    Description

    History of myocardial infarction

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1275835
    SNOMED CT 2011_0131
    399211009
    Acute myocarditis according to Dallas criteria
    Description

    Acute myocarditis according to Dallas criteria

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0155686
    SNOMED CT 2011_0131
    46701001
    MedDRA 14.1
    10000932
    ICD-10-CM Version 2010
    I40.9
    ICD-9-CM Version 2011
    422.90
    UMLS CUI 2011AA
    C1706462
    UMLS CUI 2011AA
    C0679228
    Endocrine disorder excluding insulin-dependent diabetes mellitus
    Description

    Endocrine disorder excluding insulin-dependent diabetes mellitus

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0014130
    SNOMED CT 2011_0131
    362969004
    MedDRA 14.1
    10014695
    LOINC Version 232
    MTHU021570
    ICD-10-CM Version 2010
    E34.9
    ICD-9-CM Version 2011
    259.9
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C0011854
    SNOMED CT 2011_0131
    46635009
    MedDRA 14.1
    10067584
    LOINC Version 232
    MTHU020217
    ICD-10-CM Version 2010
    E10
    Implanted cardiac defibrillator (ICD) <1 month before screening date
    Description

    Implanted cardiac defibrillator (ICD) <1 month before screening date

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021102
    SNOMED CT 2011_0131
    40388003
    UMLS CUI 2011AA
    CL383027
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    Cardiac resynchronization therapy (CRT) <6 months before screening date
    Description

    Cardiac resynchronization therapy (CRT) <6 months before screening date

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1167956
    MedDRA 14.1
    10059862
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v. administration of diuretics.
    Description

    I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v. administration of diuretics.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0348016
    SNOMED CT 2011_0131
    255560000
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0304509
    SNOMED CT 2011_0131
    111139005
    UMLS CUI 2011AA
    C0042402
    SNOMED CT 2011_0131
    58944007
    UMLS CUI 2011AA
    C0205341
    SNOMED CT 2011_0131
    27582007
    UMLS CUI 2011AA
    C0013125
    UMLS CUI 2011AA
    C0439228
    SNOMED CT 2011_0131
    258703001
    HL7 V3 2006_05
    D
    UMLS CUI 2011AA
    C0012798
    SNOMED CT 2011_0131
    372695000
    LOINC Version 232
    MTHU003217
    Active infectious disease, or signs of ongoing infection with CRP >10mmol/L
    Description

    Active infectious disease, or signs of ongoing infection with CRP >10mmol/L

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    40733004
    MedDRA 14.1
    10021881
    LOINC Version 232
    MTHU034915
    ICD-9-CM Version 2011
    136.9
    UMLS CUI 2011AA
    C0220912
    UMLS CUI 2011AA
    C0549178
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    257551009
    MedDRA 14.1
    10021789
    UMLS CUI 2011AA
    C0006560
    SNOMED CT 2011_0131
    61425002
    LOINC Version 232
    MTHU002335
    Impaired renal function (serum creatinine >220 µmol/L)
    Description

    Impaired renal function (serum creatinine >220 µmol/L)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1565489
    Any disease requiring immunosuppressive drugs
    Description

    Any disease requiring immunosuppressive drugs

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0021081
    SNOMED CT 2011_0131
    372823004, 69431002
    Anaemia (haemoglobin below 90 g/L) due to other causes than CHF
    Description

    Anaemia (haemoglobin below 90 g/L) due to other causes than CHF

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0002871
    SNOMED CT 2011_0131
    271737000
    MedDRA 14.1
    10002034
    LOINC Version 232
    MTHU020823
    ICD-10-CM Version 2010
    D64.9
    ICD-9-CM Version 2011
    285.9
    CTCAE 1105E
    E10010
    UMLS CUI 2011AA
    C0019046
    SNOMED CT 2011_0131
    38082009
    MedDRA 14.1
    10019481
    LOINC Version 232
    LP14449-0
    UMLS CUI 2011AA
    CL384716
    UMLS CUI 2011AA
    C1314792
    SNOMED CT 2011_0131
    134198009
    UMLS CUI 2011AA
    CL411789
    UMLS CUI 2011AA
    C0018802
    SNOMED CT 2011_0131
    42343007
    MedDRA 14.1
    10007559
    LOINC Version 232
    MTHU020787
    ICD-10-CM Version 2010
    I50.9
    ICD-9-CM Version 2011
    428.0
    Pregnancy or lactation, or childbearing potential without appropriate contraception
    Description

    Pregnancy or lactation, or childbearing potential without appropriate contraception

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206
    UMLS CUI 2011AA
    C0006147
    Alcohol or drug abuse
    Description

    Alcohol or drug abuse

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0237123
    Presence of a malignant tumour, or remission of malignancy < 5 years
    Description

    Presence of a malignant tumour, or remission of malignancy < 5 years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C0544452
    SNOMED CT 2011_0131
    277022003
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    Suspected poor capability to follow instructions and cooperate
    Description

    Suspected poor capability to follow instructions and cooperate

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0750491
    SNOMED CT 2011_0131
    415684004
    UMLS CUI 2011AA
    C0205169
    SNOMED CT 2011_0131
    556001
    UMLS CUI 2011AA
    C2698977
    SNOMED CT 2011_0131
    415684004
    UMLS CUI 2011AA
    C0302828
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0424350
    SNOMED CT 2011_0131
    248042003
    Another life-threatening disease with poor prognosis (survival < 2 years)
    Description

    Another life-threatening disease with poor prognosis (survival < 2 years)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C1610642
    SNOMED CT 2011_0131
    440181000
    UMLS CUI 2011AA
    C0278252
    SNOMED CT 2011_0131
    170969009
    UMLS CUI 2011AA
    C0220921
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    Participation in any other clinical study within < 30 days prior to screening date
    Description

    Participation in any other clinical study within < 30 days prior to screening date

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0439228
    SNOMED CT 2011_0131
    258703001
    HL7 V3 2006_05
    D
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0011008
    SNOMED CT 2011_0131
    410671006
    LOINC Version 232
    MTHU021546
    Previous treatments with IA or immunoglobulin
    Description

    Previous treatments with IA or immunoglobulin

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1514463
    UMLS CUI 2011AA
    C0301904
    SNOMED CT 2011_0131
    33066005
    UMLS CUI 2011AA
    C0021027
    SNOMED CT 2011_0131
    399771004
    HL7 V3 2006_05
    14
    Contraindications for application of echocardiography contrast agent (Luminity(R) according to Luminity(R) specifications, including cardiac shunts, pulmonary vascular compromise)
    Description

    Contraindications for application of echocardiography contrast agent (Luminity(R) according to Luminity(R) specifications, including cardiac shunts, pulmonary vascular compromise)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1301624
    SNOMED CT 2011_0131
    397745006
    UMLS CUI 2011AA
    CL025718
    UMLS CUI 2011AA
    C0013518
    SNOMED CT 2011_0131
    433231002
    UMLS CUI 2011AA
    C1254351
    UMLS CUI 2011AA
    C0937858
    SNOMED CT 2011_0131
    409292001
    UMLS CUI 2011AA
    C2348235
    LOINC Version 232
    MTHU032336
    UMLS CUI 2011AA
    C0332257
    SNOMED CT 2011_0131
    55919000
    UMLS CUI 2011AA
    C0232180
    SNOMED CT 2011_0131
    442119001
    UMLS CUI 2011AA
    C0854416
    MedDRA 14.1
    10061474
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age 18 Years to 65 Years
    Item
    age 18 Years to 65 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Dilated cardiomyopathy
    Item
    Dilated cardiomyopathy
    boolean
    C0007193 (UMLS CUI 2011AA)
    195021004 (SNOMED CT 2011_0131)
    10056419 (MedDRA 14.1)
    I42.0 (ICD-10-CM Version 2010)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    LVEF <= 40% determined by contrast echocardiography
    Item
    LVEF <= 40% determined by contrast echocardiography
    boolean
    C0428772 (UMLS CUI 2011AA)
    250908004 (SNOMED CT 2011_0131)
    10069170 (MedDRA 14.1)
    C0521095 (UMLS CUI 2011AA)
    436000 (SNOMED CT 2011_0131)
    C0013518 (UMLS CUI 2011AA)
    433231002 (SNOMED CT 2011_0131)
    NYHA class II - IV
    Item
    NYHA class II - IV
    boolean
    C1319794 (UMLS CUI 2011AA)
    421704003 (SNOMED CT 2011_0131)
    10064080 (MedDRA 14.1)
    C1319795 (UMLS CUI 2011AA)
    420913000 (SNOMED CT 2011_0131)
    10064081 (MedDRA 14.1)
    C1319796 (UMLS CUI 2011AA)
    422293003 (SNOMED CT 2011_0131)
    10064082 (MedDRA 14.1)
    Age 18 - 65
    Item
    Age 18 - 65
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Disease duration: symptomatic heart failure >1 year and <5 years prior to screening date
    Item
    Disease duration: symptomatic heart failure >1 year and <5 years prior to screening date
    boolean
    C0872146 (UMLS CUI 2011AA)
    C0231220 (UMLS CUI 2011AA)
    264931009 (SNOMED CT 2011_0131)
    C0018801 (UMLS CUI 2011AA)
    155374007 (SNOMED CT 2011_0131)
    10019279 (MedDRA 14.1)
    428 (ICD-9-CM Version 2011)
    E10124 (CTCAE 1105E)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.
    Item
    Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.
    boolean
    C0039798 (UMLS CUI 2011AA)
    C0003015 (UMLS CUI 2011AA)
    372733002 (SNOMED CT 2011_0131)
    C0521942 (UMLS CUI 2011AA)
    372913009 (SNOMED CT 2011_0131)
    C0001645 (UMLS CUI 2011AA)
    33252009 (SNOMED CT 2011_0131)
    MTHU003324 (LOINC Version 232)
    C0002007 (UMLS CUI 2011AA)
    372603003 (SNOMED CT 2011_0131)
    C1320929 (UMLS CUI 2011AA)
    405279007 (SNOMED CT 2011_0131)
    ATTPHYS (HL7 V3 2006_05)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0205360 (UMLS CUI 2011AA)
    58158008 (SNOMED CT 2011_0131)
    MTHU015276 (LOINC Version 232)
    C0178602 (UMLS CUI 2011AA)
    260911001 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    The patient's informed consent
    Item
    Informed Consent
    boolean
    C0021430 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
    Item
    NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
    boolean
    C1319796 (UMLS CUI 2011AA)
    422293003 (SNOMED CT 2011_0131)
    10064082 (MedDRA 14.1)
    C0425251 (UMLS CUI 2011AA)
    160685001 (SNOMED CT 2011_0131)
    MTHU008262 (LOINC Version 232)
    CL414916 (UMLS CUI 2011AA)
    C1518896 (UMLS CUI 2011AA)
    C0013227 (UMLS CUI 2011AA)
    Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, >= 50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects >second degree
    Item
    Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, >= 50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects >second degree
    boolean
    C0018801 (UMLS CUI 2011AA)
    155374007 (SNOMED CT 2011_0131)
    10019279 (MedDRA 14.1)
    428 (ICD-9-CM Version 2011)
    E10124 (CTCAE 1105E)
    C1274040 (UMLS CUI 2011AA)
    79409006 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0010068 (UMLS CUI 2011AA)
    53741008 (SNOMED CT 2011_0131)
    10068617 (MedDRA 14.1)
    C0679403 (UMLS CUI 2011AA)
    10057469 (MedDRA 14.1)
    C0085532 (UMLS CUI 2011AA)
    33367005 (SNOMED CT 2011_0131)
    10003200 (MedDRA 14.1)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    C0152105 (UMLS CUI 2011AA)
    64715009 (SNOMED CT 2011_0131)
    10020823 (MedDRA 14.1)
    I11 (ICD-10-CM Version 2010)
    402 (ICD-9-CM Version 2011)
    C2748945 (UMLS CUI 2011AA)
    C0449286 (UMLS CUI 2011AA)
    246173007 (SNOMED CT 2011_0131)
    History of myocardial infarction
    Item
    History of - myocardial infarction
    boolean
    C1275835 (UMLS CUI 2011AA)
    399211009 (SNOMED CT 2011_0131)
    Acute myocarditis according to Dallas criteria
    Item
    Acute myocarditis according to Dallas criteria
    boolean
    C0155686 (UMLS CUI 2011AA)
    46701001 (SNOMED CT 2011_0131)
    10000932 (MedDRA 14.1)
    I40.9 (ICD-10-CM Version 2010)
    422.90 (ICD-9-CM Version 2011)
    C1706462 (UMLS CUI 2011AA)
    C0679228 (UMLS CUI 2011AA)
    Endocrine disorder excluding insulin-dependent diabetes mellitus
    Item
    Endocrine disorder excluding insulin-dependent diabetes mellitus
    boolean
    C0014130 (UMLS CUI 2011AA)
    362969004 (SNOMED CT 2011_0131)
    10014695 (MedDRA 14.1)
    MTHU021570 (LOINC Version 232)
    E34.9 (ICD-10-CM Version 2010)
    259.9 (ICD-9-CM Version 2011)
    CL411789 (UMLS CUI 2011AA)
    C0011854 (UMLS CUI 2011AA)
    46635009 (SNOMED CT 2011_0131)
    10067584 (MedDRA 14.1)
    MTHU020217 (LOINC Version 232)
    E10 (ICD-10-CM Version 2010)
    Implanted cardiac defibrillator (ICD) <1 month before screening date
    Item
    Implanted cardiac defibrillator (ICD) <1 month before screening date
    boolean
    C0021102 (UMLS CUI 2011AA)
    40388003 (SNOMED CT 2011_0131)
    CL383027 (UMLS CUI 2011AA)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    Cardiac resynchronization therapy (CRT) <6 months before screening date
    Item
    Cardiac resynchronization therapy (CRT) <6 months before screening date
    boolean
    C1167956 (UMLS CUI 2011AA)
    10059862 (MedDRA 14.1)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v. administration of diuretics.
    Item
    I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v. administration of diuretics.
    boolean
    C0348016 (UMLS CUI 2011AA)
    255560000 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    C0304509 (UMLS CUI 2011AA)
    111139005 (SNOMED CT 2011_0131)
    C0042402 (UMLS CUI 2011AA)
    58944007 (SNOMED CT 2011_0131)
    C0205341 (UMLS CUI 2011AA)
    27582007 (SNOMED CT 2011_0131)
    C0013125 (UMLS CUI 2011AA)
    C0439228 (UMLS CUI 2011AA)
    258703001 (SNOMED CT 2011_0131)
    D (HL7 V3 2006_05)
    C0012798 (UMLS CUI 2011AA)
    372695000 (SNOMED CT 2011_0131)
    MTHU003217 (LOINC Version 232)
    Active infectious disease, or signs of ongoing infection with CRP >10mmol/L
    Item
    Active infectious disease, or signs of ongoing infection with CRP >10mmol/L
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0009450 (UMLS CUI 2011AA)
    40733004 (SNOMED CT 2011_0131)
    10021881 (MedDRA 14.1)
    MTHU034915 (LOINC Version 232)
    136.9 (ICD-9-CM Version 2011)
    C0220912 (UMLS CUI 2011AA)
    C0549178 (UMLS CUI 2011AA)
    C0009450 (UMLS CUI 2011AA)
    257551009 (SNOMED CT 2011_0131)
    10021789 (MedDRA 14.1)
    C0006560 (UMLS CUI 2011AA)
    61425002 (SNOMED CT 2011_0131)
    MTHU002335 (LOINC Version 232)
    Impaired renal function (serum creatinine >220 µmol/L)
    Item
    Impaired renal function (serum creatinine >220 µmol/L)
    boolean
    C1565489 (UMLS CUI 2011AA)
    Any disease requiring immunosuppressive drugs
    Item
    Any disease requiring immunosuppressive drugs
    boolean
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    C0021081 (UMLS CUI 2011AA)
    372823004, 69431002 (SNOMED CT 2011_0131)
    Anaemia (haemoglobin below 90 g/L) due to other causes than CHF
    Item
    Anaemia (haemoglobin below 90 g/L) due to other causes than CHF
    boolean
    C0002871 (UMLS CUI 2011AA)
    271737000 (SNOMED CT 2011_0131)
    10002034 (MedDRA 14.1)
    MTHU020823 (LOINC Version 232)
    D64.9 (ICD-10-CM Version 2010)
    285.9 (ICD-9-CM Version 2011)
    E10010 (CTCAE 1105E)
    C0019046 (UMLS CUI 2011AA)
    38082009 (SNOMED CT 2011_0131)
    10019481 (MedDRA 14.1)
    LP14449-0 (LOINC Version 232)
    CL384716 (UMLS CUI 2011AA)
    C1314792 (UMLS CUI 2011AA)
    134198009 (SNOMED CT 2011_0131)
    CL411789 (UMLS CUI 2011AA)
    C0018802 (UMLS CUI 2011AA)
    42343007 (SNOMED CT 2011_0131)
    10007559 (MedDRA 14.1)
    MTHU020787 (LOINC Version 232)
    I50.9 (ICD-10-CM Version 2010)
    428.0 (ICD-9-CM Version 2011)
    Pregnancy or lactation, or childbearing potential without appropriate contraception
    Item
    Pregnancy or lactation, or childbearing potential without appropriate contraception
    boolean
    C0549206 (UMLS CUI 2011AA)
    C0006147 (UMLS CUI 2011AA)
    Alcohol or drug abuse
    Item
    Alcohol or drug abuse
    boolean
    C0237123 (UMLS CUI 2011AA)
    Presence of a malignant tumour, or remission of malignancy < 5 years
    Item
    Presence of a malignant tumour, or remission of malignancy < 5 years
    boolean
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    C0150312 (UMLS CUI 2011AA)
    52101004 (SNOMED CT 2011_0131)
    C0544452 (UMLS CUI 2011AA)
    277022003 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    Suspected poor capability to follow instructions and cooperate
    Item
    Suspected poor capability to follow instructions and cooperate
    boolean
    C0750491 (UMLS CUI 2011AA)
    415684004 (SNOMED CT 2011_0131)
    C0205169 (UMLS CUI 2011AA)
    556001 (SNOMED CT 2011_0131)
    C2698977 (UMLS CUI 2011AA)
    415684004 (SNOMED CT 2011_0131)
    C0302828 (UMLS CUI 2011AA)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0424350 (UMLS CUI 2011AA)
    248042003 (SNOMED CT 2011_0131)
    Another life-threatening disease with poor prognosis (survival < 2 years)
    Item
    Another life-threatening disease with poor prognosis (survival < 2 years)
    boolean
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C1610642 (UMLS CUI 2011AA)
    440181000 (SNOMED CT 2011_0131)
    C0278252 (UMLS CUI 2011AA)
    170969009 (SNOMED CT 2011_0131)
    C0220921 (UMLS CUI 2011AA)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    Participation in any other clinical study within < 30 days prior to screening date
    Item
    Participation in any other clinical study within < 30 days prior to screening date
    boolean
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0439228 (UMLS CUI 2011AA)
    258703001 (SNOMED CT 2011_0131)
    D (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1409616 (UMLS CUI 2011AA)
    C0011008 (UMLS CUI 2011AA)
    410671006 (SNOMED CT 2011_0131)
    MTHU021546 (LOINC Version 232)
    Previous treatments with IA or immunoglobulin
    Item
    Previous treatments with IA or immunoglobulin
    boolean
    C1514463 (UMLS CUI 2011AA)
    C0301904 (UMLS CUI 2011AA)
    33066005 (SNOMED CT 2011_0131)
    C0021027 (UMLS CUI 2011AA)
    399771004 (SNOMED CT 2011_0131)
    14 (HL7 V3 2006_05)
    Contraindications for application of echocardiography contrast agent (Luminity(R) according to Luminity(R) specifications, including cardiac shunts, pulmonary vascular compromise)
    Item
    Contraindications for application of echocardiography contrast agent (Luminity(R) according to Luminity(R) specifications, including cardiac shunts, pulmonary vascular compromise)
    boolean
    C1301624 (UMLS CUI 2011AA)
    397745006 (SNOMED CT 2011_0131)
    CL025718 (UMLS CUI 2011AA)
    C0013518 (UMLS CUI 2011AA)
    433231002 (SNOMED CT 2011_0131)
    C1254351 (UMLS CUI 2011AA)
    C0937858 (UMLS CUI 2011AA)
    409292001 (SNOMED CT 2011_0131)
    C2348235 (UMLS CUI 2011AA)
    MTHU032336 (LOINC Version 232)
    C0332257 (UMLS CUI 2011AA)
    55919000 (SNOMED CT 2011_0131)
    C0232180 (UMLS CUI 2011AA)
    442119001 (SNOMED CT 2011_0131)
    C0854416 (UMLS CUI 2011AA)
    10061474 (MedDRA 14.1)
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