ID

39450

Descrição

Cardiac Magnetic Resonance Imaging Guided Left Ventricular Lead Placement; ODM derived from: https://clinicaltrials.gov/show/NCT01417624

Link

https://clinicaltrials.gov/show/NCT01417624

Palavras-chave

  1. 11/01/2020 11/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de janeiro de 2020

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01417624

Eligibility Heart Failure NCT01417624

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to give written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
age >18 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
successful crt implantation (with or without a defibrillator)
Descrição

Implantation of CRT-D with Defibrillator | Implantation of CRT-D

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0180307
UMLS CUI [2]
C1135480
nyha class iii-iv heart failure (or nyha ii with nyha iii/iv symptoms in the preceding 12 months)
Descrição

Heart failure New York Heart Association Classification | Symptoms New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1275491
lvef <35% (calculated using echocardiography or cardiac mr) at the time of implantation
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0412692
qrs duration > 120ms with left bundle branch block morphology on ecg
Descrição

QRS duration | ECG Left bundle branch block

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0429025
UMLS CUI [2]
C0344420
sinus rhythm
Descrição

Sinus rhythm

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232201
optimal tolerated medical therapy for heart failure
Descrição

Therapy Optimal Heart failure

Tipo de dados

boolean

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

Exclusion Criteria

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

Life threatening illness Severe | Exception Heart Disease

Tipo de dados

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
Descrição

Malignant disease | Malignant disease Recent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C0442867
UMLS CUI [2,2]
C0332185
prior heart transplant
Descrição

Heart Transplantation Previous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0205156
recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrollment into the study
Descrição

Angina, Unstable | Acute Coronary Syndrome | Myocardial Infarction

Tipo de dados

boolean

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

Pregnancy

Tipo de dados

boolean

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

Informed Consent failed

Tipo de dados

boolean

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

Atrial Fibrillation

Tipo de dados

boolean

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

Cardiac pacemaker in situ

Tipo de dados

boolean

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

Heart failure Requirement Intravenous therapy | Heart failure Requirement Diuretics | Heart failure Requirement Inotropic agent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0455142
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0012798
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0304509
recent revascularisation procedure i.e. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci) within the last three months
Descrição

Revascularization Recent | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0581603
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
contraindications to a cmr study
Descrição

Medical contraindication Magnetic Resonance Imaging of Heart

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0412692

Similar models

Eligibility Heart Failure NCT01417624

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age >18 years old
boolean
C0001779 (UMLS CUI [1])
Implantation of CRT-D with Defibrillator | Implantation of CRT-D
Item
successful crt implantation (with or without a defibrillator)
boolean
C1135480 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0180307 (UMLS CUI [1,3])
C1135480 (UMLS CUI [2])
Heart failure New York Heart Association Classification | Symptoms 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])
C1457887 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
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 | ECG Left bundle branch block
Item
qrs duration > 120ms with left bundle branch block morphology on ecg
boolean
C0429025 (UMLS CUI [1])
C0344420 (UMLS CUI [2])
Sinus rhythm
Item
sinus rhythm
boolean
C0232201 (UMLS CUI [1])
Therapy 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 disease | Malignant disease Recent
Item
active malignant disease and recent (<5 years) malignant disease
boolean
C0442867 (UMLS CUI [1])
C0442867 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Heart Transplantation Previous
Item
prior heart transplant
boolean
C0018823 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Angina, Unstable | Acute Coronary Syndrome | Myocardial Infarction
Item
recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrollment 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 Intravenous therapy | Heart failure Requirement Diuretics | Heart failure Requirement 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])
C0455142 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0012798 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0304509 (UMLS CUI [3,3])
Revascularization Recent | 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 [1,1])
C0332185 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Medical contraindication Magnetic Resonance Imaging of Heart
Item
contraindications to a cmr study
boolean
C1301624 (UMLS CUI [1,1])
C0412692 (UMLS CUI [1,2])

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