ID

39627

Beskrivning

Predictives Factors of Cardiac Resynchronization Therapy: a Multimodal Analysis Using 2D Speckle Tracking Echocardiography Coupled With MIBG Myocardial Scintigraphy and Heart Failure Biomarkers; ODM derived from: https://clinicaltrials.gov/show/NCT02018029

Länk

https://clinicaltrials.gov/show/NCT02018029

Nyckelord

Versioner (1)
  1. 2020-02-05 2020-02-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02018029

Engelsk

Eligibility Heart Failure NCT02018029

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 year's old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patient eligible to crt according guidelines of esc 2012:
Beskrivning

Eligibility Cardiac Resynchronization Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1167956
qrs ≥ 120 ms and lvef ≤ 35% and appearance typical block left arm and nyha iii and iv in sinus rhythm, qrs ≥ 150 ms and lvef ≤ 35 % non- appearance block left leg nyha iii and iv in sinus rhythm, qrs ≥ 130 ms and lvef ≤ 30% and appearance typical of lbbb nyha ii
Beskrivning

QRS duration | Left ventricular ejection fraction | Nerve conduction block Left arm | New York Heart Association Classification | Sinus rhythm | Nerve conduction block Absent Left leg | Left Bundle-Branch Block

Datatyp

boolean

Alias
UMLS CUI [1]
C0429025
UMLS CUI [2]
C0428772
UMLS CUI [3,1]
C4012631
UMLS CUI [3,2]
C0230347
UMLS CUI [4]
C1275491
UMLS CUI [5]
C0232201
UMLS CUI [6,1]
C4012631
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0230443
UMLS CUI [7]
C0023211
life expectancy expected to exceed one year with a good functional status
Beskrivning

Life Expectancy | Functional Status Good

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0598463
UMLS CUI [2,2]
C0205170
optimal pharmacological treatment of heart failure
Beskrivning

Pharmacotherapy Optimal Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
contraindications to the crt
Beskrivning

Medical contraindication Cardiac Resynchronization Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1167956
fast atrial fibrillation
Beskrivning

Atrial Fibrillation fast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0456962
taking a treatment interfering with the binding of mibg and can not be interrupted before the scan
Beskrivning

Treatment Interferes with MIBG scintiscan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2229074
contraindications to performing a scan [hypersensitivity to the active substance (2-methoxy-isobutyl-isonitrile-(99mtc)and iobenguane-(123l)) or any of the excipients, pregnancy, breastfeeding]
Beskrivning

Medical contraindication Scan | Hypersensitivity Iobenguane I-123 | Hypersensitivity Iobenguane I-123 Excipient | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0441633
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2369192
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2369192
UMLS CUI [3,3]
C0015237
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0006147
contraindication to achieve an uncontrolled stress test [myocardial infarction in acute or very recent, unstable angina, prevent ventricular ejection (aortic stenosis, pulmonary stenosis, obstructive cardiomyopathy), severe hypertension, ventricular arrhythmia, and in all cases where it may be poorly tolerated : severe anemia , respiratory insufficiency, peripheral arterial disease, inability to walk or cycle ... ]
Beskrivning

Medical contraindication Stress Test Uncontrolled | Myocardial Infarction | Recent myocardial infarction | Angina, Unstable | Preventing Ventricular ejection | Aortic Valve Stenosis | Pulmonary Stenosis | Hypertrophic Cardiomyopathy | Hypertension, severe | Ventricular arrhythmia | Anemia, severe | Respiratory Insufficiency | Peripheral Arterial Diseases | Lacking Able to walk | Lacking Able to ride a bicycle

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3494508
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1998297
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C1292733
UMLS CUI [5,2]
C2733340
UMLS CUI [6]
C0003507
UMLS CUI [7]
C1956257
UMLS CUI [8]
C0007194
UMLS CUI [9]
C4013784
UMLS CUI [10]
C0085612
UMLS CUI [11]
C0238644
UMLS CUI [12]
C0035229
UMLS CUI [13]
C1704436
UMLS CUI [14,1]
C0332268
UMLS CUI [14,2]
C2712089
UMLS CUI [15,1]
C0332268
UMLS CUI [15,2]
C0577366
no affiliation to the french social security system
Beskrivning

Social security system Affiliation Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2371809
UMLS CUI [1,2]
C1510825
UMLS CUI [1,3]
C0332197
refusal to participate
Beskrivning

Study Subject Participation Status | Refusal to Participate

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1136454
incapacity
Beskrivning

Legal capacity Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Heart Failure NCT02018029

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients over 18 year's old
boolean
C0001779 (UMLS CUI [1])
Eligibility Cardiac Resynchronization Therapy
Item
patient eligible to crt according guidelines of esc 2012:
boolean
C1548635 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
QRS duration | Left ventricular ejection fraction | Nerve conduction block Left arm | New York Heart Association Classification | Sinus rhythm | Nerve conduction block Absent Left leg | Left Bundle-Branch Block
Item
qrs ≥ 120 ms and lvef ≤ 35% and appearance typical block left arm and nyha iii and iv in sinus rhythm, qrs ≥ 150 ms and lvef ≤ 35 % non- appearance block left leg nyha iii and iv in sinus rhythm, qrs ≥ 130 ms and lvef ≤ 30% and appearance typical of lbbb nyha ii
boolean
C0429025 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C4012631 (UMLS CUI [3,1])
C0230347 (UMLS CUI [3,2])
C1275491 (UMLS CUI [4])
C0232201 (UMLS CUI [5])
C4012631 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0230443 (UMLS CUI [6,3])
C0023211 (UMLS CUI [7])
Life Expectancy | Functional Status Good
Item
life expectancy expected to exceed one year with a good functional status
boolean
C0023671 (UMLS CUI [1])
C0598463 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
Pharmacotherapy Optimal Heart failure
Item
optimal pharmacological treatment of heart failure
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Medical contraindication Cardiac Resynchronization Therapy
Item
contraindications to the crt
boolean
C1301624 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
Atrial Fibrillation fast
Item
fast atrial fibrillation
boolean
C0004238 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
Treatment Interferes with MIBG scintiscan
Item
taking a treatment interfering with the binding of mibg and can not be interrupted before the scan
boolean
C0087111 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2229074 (UMLS CUI [1,3])
Medical contraindication Scan | Hypersensitivity Iobenguane I-123 | Hypersensitivity Iobenguane I-123 Excipient | Pregnancy | Breast Feeding
Item
contraindications to performing a scan [hypersensitivity to the active substance (2-methoxy-isobutyl-isonitrile-(99mtc)and iobenguane-(123l)) or any of the excipients, pregnancy, breastfeeding]
boolean
C1301624 (UMLS CUI [1,1])
C0441633 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2369192 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2369192 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
Medical contraindication Stress Test Uncontrolled | Myocardial Infarction | Recent myocardial infarction | Angina, Unstable | Preventing Ventricular ejection | Aortic Valve Stenosis | Pulmonary Stenosis | Hypertrophic Cardiomyopathy | Hypertension, severe | Ventricular arrhythmia | Anemia, severe | Respiratory Insufficiency | Peripheral Arterial Diseases | Lacking Able to walk | Lacking Able to ride a bicycle
Item
contraindication to achieve an uncontrolled stress test [myocardial infarction in acute or very recent, unstable angina, prevent ventricular ejection (aortic stenosis, pulmonary stenosis, obstructive cardiomyopathy), severe hypertension, ventricular arrhythmia, and in all cases where it may be poorly tolerated : severe anemia , respiratory insufficiency, peripheral arterial disease, inability to walk or cycle ... ]
boolean
C1301624 (UMLS CUI [1,1])
C3494508 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C1998297 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C1292733 (UMLS CUI [5,1])
C2733340 (UMLS CUI [5,2])
C0003507 (UMLS CUI [6])
C1956257 (UMLS CUI [7])
C0007194 (UMLS CUI [8])
C4013784 (UMLS CUI [9])
C0085612 (UMLS CUI [10])
C0238644 (UMLS CUI [11])
C0035229 (UMLS CUI [12])
C1704436 (UMLS CUI [13])
C0332268 (UMLS CUI [14,1])
C2712089 (UMLS CUI [14,2])
C0332268 (UMLS CUI [15,1])
C0577366 (UMLS CUI [15,2])
Social security system Affiliation Absent
Item
no affiliation to the french social security system
boolean
C2371809 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status | Refusal to Participate
Item
refusal to participate
boolean
C2348568 (UMLS CUI [1])
C1136454 (UMLS CUI [2])
Legal capacity Lacking
Item
incapacity
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Tillbaka till toppen 

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