ID

39482

Description

Selection of Potential Predictors of Worsening Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01836510

Link

https://clinicaltrials.gov/show/NCT01836510

Keywords

Versions (1)
  1. 1/16/20 1/16/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 16, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01836510

English

Eligibility Heart Failure NCT01836510

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
left ventricular ejection fraction (lvef) ≤ 35%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
nyha class ii or iii heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
men and women 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
understand the nature of the procedure
Description

Comprehension Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0184661
give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no indication or contraindication for icd or crt-d therapy
Description

Indication Absent Implantable defibrillator | Indication Absent Cardiac Resynchronization Therapy Defibrillator (CRT-D) Systems | Medical contraindication Absent Implantable defibrillator | Medical contraindication Absent Cardiac Resynchronization Therapy Defibrillator (CRT-D) Systems

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0162589
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1736558
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0162589
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C1736558
permanent af
Description

Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
nyha class iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
subjects with irreversible brain damage from preexisting cerebral disease;
Description

Brain damage | Etiology Cerebral disorder Pre-existing

Data type

boolean

Alias
UMLS CUI [1]
C0270611
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0234387
UMLS CUI [2,3]
C2347662
subjects with acutely decompensated heart failure
Description

Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1]
C0581377
expected heart transplantation within next six months or planned cardiac surgery within next 3 months
Description

Heart Transplantation Expected | Cardiac Surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C1301732
have a life expectancy of less than six months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer)
Description

Disease Associated with Reduced life expectancy | Exception Heart Disease | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1858274
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0006826
unstable geographical residence (unable to anticipate to be resident in the area of the referring participating centre during the study period) and/or gsm-free residence
Description

Residence Unstable | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C3846158
subjects who were not been implanted with icd or crt-d devices compatible with hm transmissions
Description

Implantable defibrillator Absent | Implantation of CRT-D Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1135480
UMLS CUI [2,2]
C0332197
age <18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Heart Failure NCT01836510

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) ≤ 35%
boolean
C0428772 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
nyha class ii or iii heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Age
Item
men and women 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Comprehension Procedure
Item
understand the nature of the procedure
boolean
C0162340 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Informed Consent
Item
give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Indication Absent Implantable defibrillator | Indication Absent Cardiac Resynchronization Therapy Defibrillator (CRT-D) Systems | Medical contraindication Absent Implantable defibrillator | Medical contraindication Absent Cardiac Resynchronization Therapy Defibrillator (CRT-D) Systems
Item
no indication or contraindication for icd or crt-d therapy
boolean
C3146298 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0162589 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1736558 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0162589 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1736558 (UMLS CUI [4,3])
Permanent atrial fibrillation
Item
permanent af
boolean
C2586056 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
nyha class iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Brain damage | Etiology Cerebral disorder Pre-existing
Item
subjects with irreversible brain damage from preexisting cerebral disease;
boolean
C0270611 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0234387 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
Decompensated cardiac failure
Item
subjects with acutely decompensated heart failure
boolean
C0581377 (UMLS CUI [1])
Heart Transplantation Expected | Cardiac Surgery Planned
Item
expected heart transplantation within next six months or planned cardiac surgery within next 3 months
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Life Expectancy
Item
have a life expectancy of less than six months
boolean
C0023671 (UMLS CUI [1])
Disease Associated with Reduced life expectancy | Exception Heart Disease | Malignant Neoplasms
Item
presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer)
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1858274 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
Residence Unstable | Other Coding
Item
unstable geographical residence (unable to anticipate to be resident in the area of the referring participating centre during the study period) and/or gsm-free residence
boolean
C0237096 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Implantable defibrillator Absent | Implantation of CRT-D Absent
Item
subjects who were not been implanted with icd or crt-d devices compatible with hm transmissions
boolean
C0162589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1135480 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Age
Item
age <18 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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