ID

35912

Description

Predicting Response to CRT Using Body Surface ECG Mapping; ODM derived from: https://clinicaltrials.gov/show/NCT01831518

Link

https://clinicaltrials.gov/show/NCT01831518

Keywords

Versions (1)
  1. 4/3/19 4/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01831518

English

Eligibility Heart Failure NCT01831518

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
fulfils established clinical criteria for crt implantation (with or without a defibrillator)
Description

CRT Device Implantation | Implantation of CRT-D

Data type

boolean

Alias
UMLS CUI [1,1]
C2936377
UMLS CUI [1,2]
C0021107
UMLS CUI [2]
C1135480
nyha class iii-iv heart failure (or nyha ii with nyha iii/iv symptoms in the preceding 12 months)
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
lvef <35% (calculated using echocardiography or cardiac mr) at the time of implantation
Description

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MRI of Heart

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0412692
qrs duration > 130ms
Description

QRS duration

Data type

boolean

Alias
UMLS CUI [1]
C0429025
optimal tolerated medical therapy for heart failure
Description

Therapeutic procedure Optimal Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe, life threatening non cardiac disease
Description

Life threatening illness Severe | Exception Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
active malignant disease and recent (<5 years) malignant disease
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
prior heart transplant
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
Description

Angina, Unstable | Acute Coronary Syndrome | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0948089
UMLS CUI [3]
C0027051
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
failure to participate in consent process
Description

Informed Consent failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
atrial fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
conventional pacemaker in situ
Description

Cardiac pacemaker in situ

Data type

boolean

Alias
UMLS CUI [1]
C2712998
heart failure requiring constant intravenous therapy including diuretics and/or inotropes
Description

Heart failure Requirement Therapy Intravenous | Diuretics | Inotropic agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C1522726
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0304509
recent revascularisation procedure i.e. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci) within the last three months
Description

Revascularization | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0581603
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
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Similar models

Eligibility Heart Failure NCT01831518

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >18 years old
boolean
C0001779 (UMLS CUI [1])
CRT Device Implantation | Implantation of CRT-D
Item
fulfils established clinical criteria for crt implantation (with or without a defibrillator)
boolean
C2936377 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C1135480 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
nyha class iii-iv heart failure (or nyha ii with nyha iii/iv symptoms in the preceding 12 months)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MRI of Heart
Item
lvef <35% (calculated using echocardiography or cardiac mr) at the time of implantation
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0412692 (UMLS CUI [2,2])
QRS duration
Item
qrs duration > 130ms
boolean
C0429025 (UMLS CUI [1])
Therapeutic procedure Optimal Heart failure
Item
optimal tolerated medical therapy for heart failure
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Life threatening illness Severe | Exception Heart Disease
Item
severe, life threatening non cardiac disease
boolean
C3846017 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Malignant Neoplasms
Item
active malignant disease and recent (<5 years) malignant disease
boolean
C0006826 (UMLS CUI [1])
Heart Transplantation
Item
prior heart transplant
boolean
C0018823 (UMLS CUI [1])
Angina, Unstable | Acute Coronary Syndrome | Myocardial Infarction
Item
recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
boolean
C0002965 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Informed Consent failed
Item
failure to participate in consent process
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Atrial Fibrillation
Item
atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Cardiac pacemaker in situ
Item
conventional pacemaker in situ
boolean
C2712998 (UMLS CUI [1])
Heart failure Requirement Therapy Intravenous | Diuretics | Inotropic agent
Item
heart failure requiring constant intravenous therapy including diuretics and/or inotropes
boolean
C0018801 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
C0012798 (UMLS CUI [2])
C0304509 (UMLS CUI [3])
Revascularization | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
recent revascularisation procedure i.e. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci) within the last three months
boolean
C0581603 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
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