ID

29521

Description

Biomarkers to Predict CRT Response in Patients With HF (BIOCRT); ODM derived from: https://clinicaltrials.gov/show/NCT01949246

Lien

https://clinicaltrials.gov/show/NCT01949246

Mots-clés

Versions (1)
  1. 05/04/2018 05/04/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

5 avril 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01949246

Anglais

Eligibility Heart Failure NCT01949246

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
study participant with an approved indication for a crt or crt-d system.
Description

Indication Cardiac Resynchronization Therapy | Indication CRT-D System

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1167956
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1736558
1. new york heart association (nyha) class ii, iii, or iv heart failure unresponsive to drug therapy.
Description

Heart failure New York Heart Association Classification | Unresponsive to Pharmacotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0013216
2. ef < 35%.
Description

Cardiac ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0232174
3. qrs width > 120 ms.
Description

QRS duration

Type de données

boolean

Alias
UMLS CUI [1]
C0429025
study participant receiving optimal medical therapy including ace inhibitor or angiotensin receptor blocker (arb), beta-blocker, and diuretic.
Description

Therapeutic procedure Optimal | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Diuretics

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0012798
study participants with a history of significant congestive decompensation events within the last 12 months.
Description

Congestive decompensation Events

Type de données

boolean

Alias
UMLS CUI [1,1]
C1394786
UMLS CUI [1,2]
C0441471
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
nyha class i heart failure.
Description

Heart failure New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
co morbidities (e.g., cancer), which may limit lifespan < 6 months.
Description

Comorbidity Limiting Life Expectancy | Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
UMLS CUI [2]
C0006826
severe aortic stenosis (valve area < 1.0 cm2).
Description

Severe aortic stenosis Valve area

Type de données

boolean

Alias
UMLS CUI [1,1]
C3806272
UMLS CUI [1,2]
C0428817
study participants that received cardiac surgery or intervention (i.e. coronary artery bypass grafting (cabg), valve surgery, angioplasty, arthrectomy) within the preceding 90 days.
Description

Cardiac Surgery procedures | Intervention cardiac | Coronary Artery Bypass Surgery | Valve Operative Surgical Procedures | Angioplasty | Arthrectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0018787
UMLS CUI [3]
C0010055
UMLS CUI [4,1]
C1186983
UMLS CUI [4,2]
C0543467
UMLS CUI [5]
C0162577
UMLS CUI [6]
C0185244
study participants with moderate to severe chronic obstructive pulmonary disease (copd), defined as needing chronic oxygen therapy or recent hospitalization (within 30 days) for copd flare up.
Description

Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | Patient need for Oxygen Therapy chronic | Hospitalization Chronic Obstructive Airway Disease Flare-up

Type de données

boolean

Alias
UMLS CUI [1]
C0730605
UMLS CUI [2]
C0730607
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0184633
UMLS CUI [3,3]
C0205191
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0024117
UMLS CUI [4,3]
C3830105
concurrent pregnancy.
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
study participants with primary pulmonary hypertension.
Description

Primary pulmonary hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C0152171
study participants on continuous or intermittent infusion therapy for heart failure.
Description

Infusion procedures Continuous Heart failure | Infusion procedures Intermittent Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0205267
UMLS CUI [2,3]
C0018801
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Similar models

Eligibility Heart Failure NCT01949246

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy | Indication CRT-D System
Item
study participant with an approved indication for a crt or crt-d system.
boolean
C3146298 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1736558 (UMLS CUI [2,2])
Heart failure New York Heart Association Classification | Unresponsive to Pharmacotherapy
Item
1. new york heart association (nyha) class ii, iii, or iv heart failure unresponsive to drug therapy.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
Cardiac ejection fraction
Item
2. ef < 35%.
boolean
C0232174 (UMLS CUI [1])
QRS duration
Item
3. qrs width > 120 ms.
boolean
C0429025 (UMLS CUI [1])
Therapeutic procedure Optimal | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Diuretics
Item
study participant receiving optimal medical therapy including ace inhibitor or angiotensin receptor blocker (arb), beta-blocker, and diuretic.
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0012798 (UMLS CUI [5])
Congestive decompensation Events
Item
study participants with a history of significant congestive decompensation events within the last 12 months.
boolean
C1394786 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Heart failure New York Heart Association Classification
Item
nyha class i heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Comorbidity Limiting Life Expectancy | Malignant Neoplasms
Item
co morbidities (e.g., cancer), which may limit lifespan < 6 months.
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
Severe aortic stenosis Valve area
Item
severe aortic stenosis (valve area < 1.0 cm2).
boolean
C3806272 (UMLS CUI [1,1])
C0428817 (UMLS CUI [1,2])
Cardiac Surgery procedures | Intervention cardiac | Coronary Artery Bypass Surgery | Valve Operative Surgical Procedures | Angioplasty | Arthrectomy
Item
study participants that received cardiac surgery or intervention (i.e. coronary artery bypass grafting (cabg), valve surgery, angioplasty, arthrectomy) within the preceding 90 days.
boolean
C0018821 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3])
C1186983 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0162577 (UMLS CUI [5])
C0185244 (UMLS CUI [6])
Moderate chronic obstructive pulmonary disease | Severe chronic obstructive pulmonary disease | Patient need for Oxygen Therapy chronic | Hospitalization Chronic Obstructive Airway Disease Flare-up
Item
study participants with moderate to severe chronic obstructive pulmonary disease (copd), defined as needing chronic oxygen therapy or recent hospitalization (within 30 days) for copd flare up.
boolean
C0730605 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0184633 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C0019993 (UMLS CUI [4,1])
C0024117 (UMLS CUI [4,2])
C3830105 (UMLS CUI [4,3])
Pregnancy
Item
concurrent pregnancy.
boolean
C0032961 (UMLS CUI [1])
Primary pulmonary hypertension
Item
study participants with primary pulmonary hypertension.
boolean
C0152171 (UMLS CUI [1])
Infusion procedures Continuous Heart failure | Infusion procedures Intermittent Heart failure
Item
study participants on continuous or intermittent infusion therapy for heart failure.
boolean
C0574032 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0574032 (UMLS CUI [2,1])
C0205267 (UMLS CUI [2,2])
C0018801 (UMLS CUI [2,3])
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