ID

23986

Description

DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT00478933

Link

https://clinicaltrials.gov/show/NCT00478933

Keywords

Versions (1)
  1. 7/20/17 7/20/17 -
Uploaded on

July 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Death, Sudden, Cardiac NCT00478933

English

Eligibility Death, Sudden, Cardiac NCT00478933

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
implantation of a market approved medtronic dual-chamber icd with long term clinical trends cardiac compass,
Description

Implantation Dual-chamber implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0494014
subjects requiring the implantation of an icd for primary prevention according to the current aha/acc/esc guidelines,
Description

Implantation ICD Requirement Primary Prevention

Data type

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0162589
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0033144
subject able to comply with the clinical investigationplan,
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
subject is expected to remain available for follow-up visits,
Description

Study Subject Available Clinical Study Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
subject has signed the informed consent form within 10 days of implant,
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the system implanted for this study is the first icd implant for patient.
Description

ICD Implant Firstly

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C1279901
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
Description

Pregnancy | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332268
subject is enrolled in a concurrent study that may confound the results of this study,
Description

Study Subject Participation Status Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
subject has a life expectancy less than two years,
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
subject is post heart transplant or awaiting heart transplantation,
Description

Heart Transplantation Status post | Patient awaiting Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0231290
UMLS CUI [2,1]
C0554950
UMLS CUI [2,2]
C0018823
subject is anticipated to demonstrate poor compliance,
Description

Poor compliance Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C1517001
subjects with syndromes known to be associated with ion channel pathologies such as:
Description

Syndrome Associated with Ion Channel Pathology

Data type

boolean

Alias
UMLS CUI [1,1]
C0039082
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0022009
UMLS CUI [1,4]
C0205469
long- or short-qt syndrome
Description

Long QT Syndrome | Short QT Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C2348199
brugada syndrome
Description

Brugada Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1142166
catecholaminergic polymorphic ventricular tachycardia (cptv ).
Description

Catecholaminergic polymorphic ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C1631597
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Similar models

Eligibility Death, Sudden, Cardiac NCT00478933

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantation Dual-chamber implantable defibrillator
Item
implantation of a market approved medtronic dual-chamber icd with long term clinical trends cardiac compass,
boolean
C0021107 (UMLS CUI [1,1])
C0494014 (UMLS CUI [1,2])
Implantation ICD Requirement Primary Prevention
Item
subjects requiring the implantation of an icd for primary prevention according to the current aha/acc/esc guidelines,
boolean
C0021107 (UMLS CUI [1,1])
C0162589 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0033144 (UMLS CUI [1,4])
Protocol Compliance
Item
subject able to comply with the clinical investigationplan,
boolean
C0525058 (UMLS CUI [1])
Study Subject Available Clinical Study Follow-up
Item
subject is expected to remain available for follow-up visits,
boolean
C0681850 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Informed Consent
Item
subject has signed the informed consent form within 10 days of implant,
boolean
C0021430 (UMLS CUI [1])
ICD Implant Firstly
Item
the system implanted for this study is the first icd implant for patient.
boolean
C0162589 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C1279901 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Contraceptive methods Lacking
Item
women who are pregnant, or women of childbearing potential not on a reliable form of birth control,
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Study Subject Participation Status Interferes with Research results
Item
subject is enrolled in a concurrent study that may confound the results of this study,
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Life Expectancy
Item
subject has a life expectancy less than two years,
boolean
C0023671 (UMLS CUI [1])
Heart Transplantation Status post | Patient awaiting Heart Transplantation
Item
subject is post heart transplant or awaiting heart transplantation,
boolean
C0018823 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0554950 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
Poor compliance Expected
Item
subject is anticipated to demonstrate poor compliance,
boolean
C0032646 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Syndrome Associated with Ion Channel Pathology
Item
subjects with syndromes known to be associated with ion channel pathologies such as:
boolean
C0039082 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0022009 (UMLS CUI [1,3])
C0205469 (UMLS CUI [1,4])
Long QT Syndrome | Short QT Syndrome
Item
long- or short-qt syndrome
boolean
C0023976 (UMLS CUI [1])
C2348199 (UMLS CUI [2])
Brugada Syndrome
Item
brugada syndrome
boolean
C1142166 (UMLS CUI [1])
Catecholaminergic polymorphic ventricular tachycardia
Item
catecholaminergic polymorphic ventricular tachycardia (cptv ).
boolean
C1631597 (UMLS CUI [1])
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