ID

29447

Description

Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF); ODM derived from: https://clinicaltrials.gov/show/NCT00400257

Lien

https://clinicaltrials.gov/show/NCT00400257

Mots-clés

Versions (1)
  1. 25/03/2018 25/03/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

25 mars 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Heart Failure NCT00400257

Anglais

Eligibility Heart Failure NCT00400257

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥60 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. have been insured with hba for 12 months or longer (protocol amended to remove this criteria and allow enrollment of the general public)
Description

Insurance Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C0449238
3. subjects at high-risk of subsequent development of heart failure; comprising at least one of:
Description

High risk of Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0018801
prior myocardial infarction (mi) without known left ventricular (lv) dysfunction
Description

Myocardial Infarction | Left Ventricular Dysfunction Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0242698
UMLS CUI [2,2]
C0332197
current active ischemic heart disease
Description

Myocardial Ischemia

Type de données

boolean

Alias
UMLS CUI [1]
C0151744
prior cerebrovascular accident (cva)
Description

Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0038454
known valvular heart disease without known lv dysfunction
Description

Heart valve disease | Left Ventricular Dysfunction Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0018824
UMLS CUI [2,1]
C0242698
UMLS CUI [2,2]
C0332197
atrial fibrillation
Description

Atrial Fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C0004238
ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
Description

Ventricular arrhythmia Resulting in Syncope | Ventricular arrhythmia Resulting in Presyncope

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0039070
UMLS CUI [2,1]
C0085612
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0700200
treated hypertension, of at least 2 years duration
Description

Hypertensive disease Treated Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0449238
treated diabetes mellitus, of at least 2 years duration
Description

Diabetes Mellitus Treated Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0449238
estimated glomerular filtration rate (egfr) <50ml/min
Description

Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1]
C3811844
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known systolic or diastolic heart failure
Description

Heart Failure, Systolic | Heart Failure, Diastolic

Type de données

boolean

Alias
UMLS CUI [1]
C1135191
UMLS CUI [2]
C1135196
2. symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
Description

Symptoms Suggestive of Heart failure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0018801
3. lv systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
Description

Left ventricular systolic dysfunction Echocardiography | Left ventricular diastolic dysfunction Echocardiography | Left ventricular systolic dysfunction Imaging | Left ventricular diastolic dysfunction Imaging

Type de données

boolean

Alias
UMLS CUI [1,1]
C1277187
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C1273070
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C1277187
UMLS CUI [3,2]
C0079595
UMLS CUI [4,1]
C1273070
UMLS CUI [4,2]
C0079595
4. medications for treatment of heart failure such as ace inhibitors, angiotensin receptor blockers (arbs), beta-blockers or aldosterone antagonists. use of such medications for approved indications such as hypertension, post-mi management (without known lv dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
Description

Pharmaceutical Preparations Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone Antagonists | Pharmaceutical Preparations Hypertensive disease allowied| Pharmaceutical Preparations Myocardial Infarction allowed | Pharmaceutical Preparations Diabetic Nephropathy allowed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0002007
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0020538
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0027051
UMLS CUI [7,3]
C0683607
UMLS CUI [8,1]
C0013227
UMLS CUI [8,2]
C0011881
UMLS CUI [8,3]
C0683607
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Similar models

Eligibility Heart Failure NCT00400257

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥60 years
boolean
C0001779 (UMLS CUI [1])
Insurance Duration
Item
2. have been insured with hba for 12 months or longer (protocol amended to remove this criteria and allow enrollment of the general public)
boolean
C0021682 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
High risk of Heart failure
Item
3. subjects at high-risk of subsequent development of heart failure; comprising at least one of:
boolean
C0332167 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Myocardial Infarction | Left Ventricular Dysfunction Absent
Item
prior myocardial infarction (mi) without known left ventricular (lv) dysfunction
boolean
C0027051 (UMLS CUI [1])
C0242698 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Myocardial Ischemia
Item
current active ischemic heart disease
boolean
C0151744 (UMLS CUI [1])
Cerebrovascular accident
Item
prior cerebrovascular accident (cva)
boolean
C0038454 (UMLS CUI [1])
Heart valve disease | Left Ventricular Dysfunction Absent
Item
known valvular heart disease without known lv dysfunction
boolean
C0018824 (UMLS CUI [1])
C0242698 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Atrial Fibrillation
Item
atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Ventricular arrhythmia Resulting in Syncope | Ventricular arrhythmia Resulting in Presyncope
Item
ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
boolean
C0085612 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,3])
C0085612 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0700200 (UMLS CUI [2,3])
Hypertensive disease Treated Duration
Item
treated hypertension, of at least 2 years duration
boolean
C0020538 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Diabetes Mellitus Treated Duration
Item
treated diabetes mellitus, of at least 2 years duration
boolean
C0011849 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) <50ml/min
boolean
C3811844 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Failure, Systolic | Heart Failure, Diastolic
Item
1. known systolic or diastolic heart failure
boolean
C1135191 (UMLS CUI [1])
C1135196 (UMLS CUI [2])
Symptoms Suggestive of Heart failure
Item
2. symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
boolean
C1457887 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Left ventricular systolic dysfunction Echocardiography | Left ventricular diastolic dysfunction Echocardiography | Left ventricular systolic dysfunction Imaging | Left ventricular diastolic dysfunction Imaging
Item
3. lv systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
boolean
C1277187 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C1273070 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C1277187 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
C1273070 (UMLS CUI [4,1])
C0079595 (UMLS CUI [4,2])
Pharmaceutical Preparations Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Aldosterone Antagonists | Pharmaceutical Preparations Hypertensive disease allowied| Pharmaceutical Preparations Myocardial Infarction allowed | Pharmaceutical Preparations Diabetic Nephropathy allowed
Item
4. medications for treatment of heart failure such as ace inhibitors, angiotensin receptor blockers (arbs), beta-blockers or aldosterone antagonists. use of such medications for approved indications such as hypertension, post-mi management (without known lv dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
boolean
C0013227 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0002007 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0020538 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C0027051 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
C0013227 (UMLS CUI [8,1])
C0011881 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
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