Eligibility NCT00558584 Dilated Cardiomyopathy
ODM derived from http://clinicaltrials.gov/show/NCT00558584

Eligibility

  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)
C0750536 (UMLS CUI 2011AA)
C0021311 (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
C0341697 (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)