ID

39450

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01417624

Nyckelord

Versioner (1)
  1. 2020-01-11 2020-01-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01417624

Engelsk

Eligibility Heart Failure NCT01417624

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
able to give written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

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

Age

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

QRS duration | ECG Left bundle branch block

Datatyp

boolean

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

Sinus rhythm

Datatyp

boolean

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

Therapy Optimal Heart failure

Datatyp

boolean

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

Exclusion Criteria

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

Life threatening illness Severe | Exception Heart Disease

Datatyp

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
Beskrivning

Malignant disease | Malignant disease Recent

Datatyp

boolean

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

Heart Transplantation Previous

Datatyp

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
Beskrivning

Angina, Unstable | Acute Coronary Syndrome | Myocardial Infarction

Datatyp

boolean

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

Pregnancy

Datatyp

boolean

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

Informed Consent failed

Datatyp

boolean

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

Atrial Fibrillation

Datatyp

boolean

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

Cardiac pacemaker in situ

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Revascularization Recent | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Datatyp

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
Beskrivning

Medical contraindication Magnetic Resonance Imaging of Heart

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0412692
Tillbaka till toppen

Similar models

Eligibility Heart Failure NCT01417624

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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