ID

28798

Description

Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study); ODM derived from: https://clinicaltrials.gov/show/NCT00664807

Link

https://clinicaltrials.gov/show/NCT00664807

Keywords

Versions (1)
  1. 2/5/18 2/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Death, Sudden, Cardiac NCT00664807

English

Eligibility Death, Sudden, Cardiac NCT00664807

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following criteria apply to all subjects:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject has an icd or crt icd implanted
Description

Implantable cardioverter defibrillator insertion | CRT/ICD insertion

Data type

boolean

Alias
UMLS CUI [1]
C1868925
UMLS CUI [2]
C3805137
subject must be on optimal medical therapy
Description

Requirement Therapeutic procedure Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2698651
subject is a caucasian with all 4 grandparents believed to be caucasian
Description

Caucasians | Grandparents All Caucasians

Data type

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2,1]
C0337471
UMLS CUI [2,2]
C0444868
UMLS CUI [2,3]
C0043157
subject has had a myocardial infarction (mi) prior to icd implantation
Description

Myocardial Infarction prior to Implantable cardioverter defibrillator insertion

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1868925
subject is willing and able to comply with the study protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
subject is willing and able to sign and date the study informed consent and hipaa authorization (us)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
case inclusion criteria:
Description

Case Subject Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C1512693
the following criteria apply to case subjects only:
Description

Case Subject Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
subject is at least 40 years of age at time of icd implantation
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has at least one documented life-threatening arrhythmia (lta) on their icd that can transferred as a save-to-disk or has had an lta documented in their medical history. lta is defined as a true vt/vf episode with cycle length less than or equal to 400ms that was terminated by the device.
Description

Cardiac Arrhythmia Life Threatening Quantity Implantable defibrillator | Cardiac Arrhythmia Life Threatening Medical History | Ventricular Tachycardia Episode Cycle Length | Ventricular Fibrillation Episode Cycle Length

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0162589
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0042514
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1511572
UMLS CUI [3,4]
C1444754
UMLS CUI [4,1]
C0042510
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C1511572
UMLS CUI [4,4]
C1444754
control inclusion criteria:
Description

Inclusion criteria Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
the following criteria apply to control subjects only:
Description

Control Group Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
subject is currently at least 70 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has haad currently implanted medronic icd for a minimum of three years
Description

Implantable cardioverter defibrillator insertion Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1868925
UMLS CUI [1,2]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following criteria apply to all subjects:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subject has received a bone marrow or heart transplant at any time
Description

Bone Marrow Transplantation | Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0018823
subject has a previously identified cause for arrhythmias (brugada, lqt, hcm)
Description

Cause Cardiac Arrhythmia | Brugada Syndrome | Long QT Syndrome | Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0003811
UMLS CUI [2]
C1142166
UMLS CUI [3]
C0023976
UMLS CUI [4]
C0007194
control exclusion criteria:
Description

Exclusion Criteria Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0009932
the following criteria apply to control subjects only:
Description

Control Group Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
subject has had a potentially lta documented on their icd
Description

Cardiac Arrhythmia Life Threatening potential Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C3245505
UMLS CUI [1,4]
C0162589
subject was previously identified as having a ltd at any time in life
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
subject has had the memory on their icd cleared at any time in the past three years.
Description

Implantable defibrillator Memory Cleared

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C1706377
UMLS CUI [1,3]
C0521097
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Similar models

Eligibility Death, Sudden, Cardiac NCT00664807

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
the following criteria apply to all subjects:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Implantable cardioverter defibrillator insertion | CRT/ICD insertion
Item
subject has an icd or crt icd implanted
boolean
C1868925 (UMLS CUI [1])
C3805137 (UMLS CUI [2])
Requirement Therapeutic procedure Optimal
Item
subject must be on optimal medical therapy
boolean
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
Caucasians | Grandparents All Caucasians
Item
subject is a caucasian with all 4 grandparents believed to be caucasian
boolean
C0043157 (UMLS CUI [1])
C0337471 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
C0043157 (UMLS CUI [2,3])
Myocardial Infarction prior to Implantable cardioverter defibrillator insertion
Item
subject has had a myocardial infarction (mi) prior to icd implantation
boolean
C0027051 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1868925 (UMLS CUI [1,3])
Protocol Compliance
Item
subject is willing and able to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
subject is willing and able to sign and date the study informed consent and hipaa authorization (us)
boolean
C0021430 (UMLS CUI [1])
Case Subject Inclusion criteria
Item
case inclusion criteria:
boolean
C1698493 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Case Subject Criteria Fulfill
Item
the following criteria apply to case subjects only:
boolean
C1698493 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
subject is at least 40 years of age at time of icd implantation
boolean
C0001779 (UMLS CUI [1])
Cardiac Arrhythmia Life Threatening Quantity Implantable defibrillator | Cardiac Arrhythmia Life Threatening Medical History | Ventricular Tachycardia Episode Cycle Length | Ventricular Fibrillation Episode Cycle Length
Item
subject has at least one documented life-threatening arrhythmia (lta) on their icd that can transferred as a save-to-disk or has had an lta documented in their medical history. lta is defined as a true vt/vf episode with cycle length less than or equal to 400ms that was terminated by the device.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0162589 (UMLS CUI [1,4])
C0003811 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0042514 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1511572 (UMLS CUI [3,3])
C1444754 (UMLS CUI [3,4])
C0042510 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C1511572 (UMLS CUI [4,3])
C1444754 (UMLS CUI [4,4])
Inclusion criteria Control Group
Item
control inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Control Group Criteria Fulfill
Item
the following criteria apply to control subjects only:
boolean
C0009932 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Age
Item
subject is currently at least 70 years of age
boolean
C0001779 (UMLS CUI [1])
Implantable cardioverter defibrillator insertion Specified
Item
subject has haad currently implanted medronic icd for a minimum of three years
boolean
C1868925 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
the following criteria apply to all subjects:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Bone Marrow Transplantation | Heart Transplantation
Item
subject has received a bone marrow or heart transplant at any time
boolean
C0005961 (UMLS CUI [1])
C0018823 (UMLS CUI [2])
Cause Cardiac Arrhythmia | Brugada Syndrome | Long QT Syndrome | Hypertrophic Cardiomyopathy
Item
subject has a previously identified cause for arrhythmias (brugada, lqt, hcm)
boolean
C0015127 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
C1142166 (UMLS CUI [2])
C0023976 (UMLS CUI [3])
C0007194 (UMLS CUI [4])
Exclusion Criteria Control Group
Item
control exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Control Group Criteria Fulfill
Item
the following criteria apply to control subjects only:
boolean
C0009932 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Cardiac Arrhythmia Life Threatening potential Implantable defibrillator
Item
subject has had a potentially lta documented on their icd
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C3245505 (UMLS CUI [1,3])
C0162589 (UMLS CUI [1,4])
Other Coding
Item
subject was previously identified as having a ltd at any time in life
boolean
C3846158 (UMLS CUI [1])
Implantable defibrillator Memory Cleared
Item
subject has had the memory on their icd cleared at any time in the past three years.
boolean
C0162589 (UMLS CUI [1,1])
C1706377 (UMLS CUI [1,2])
C0521097 (UMLS CUI [1,3])
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