Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study) (GAME)
|ClinicalTrials.gov Identifier: NCT00664807|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : August 25, 2009
To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias.
To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association with arrhythmic events.
|Condition or disease||Phase|
|Death, Sudden, Cardiac Ventricular Fibrillation Tachycardia Atrial Fibrillation Sick Sinus Syndrome||Phase 4|
The primary objective is to establish the role of genetics in life-threatening arrhythmias leading to sudden cardiac death (SCD) and the potential utility of genetic markers in risk stratification of patients to receive an implantable cardiac defibrillator (ICD). The successful accomplishment of this goal would serve as the basis for future work on a specific diagnostic test that can be used to assess risks of threatening arrhythmias in order to quality patients for implantation of an ICD.
- to identify single nucleotide polymorphisms (SNPs) that can be used to identify individuals in need of an ICD.
The secondary objectives involve more detailed analysis to search for potentially unidentified genetic markers of risk for SCD.
- to identify genes associated with SCD susceptibility.
- to identify risk factors associated with SCD as found in the case report form (CRF).
- to correlate SNPs with co-morbidities in the subjects as found in the CRF information.
- to study the association between parameters derived from Holter recordings and predictors of life-threatening arrhythmias.
|Study Type :||Observational|
|Actual Enrollment :||1023 participants|
|Observational Model:||Case Control|
|Official Title:||Medtronic Genetic Arrhythmia Markers for Early Detection|
|Study Start Date :||April 2008|
|Primary Completion Date :||April 2009|
|Study Completion Date :||May 2009|
- Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias. [ Time Frame: one year ]
- Positive predictive value of genetic markers as predictors of life-threatening arrhythmias. [ Time Frame: one year ]
- Association between risk factors identified in the CRF and life-threatening arrhythmias. [ Time Frame: one year ]
- Correlation of SNPs to other co-morbidities identified in the CRF information. [ Time Frame: one year ]
- Association between ECG-based risk markers and life-threatening arrhythmias. [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664807
|United States, Arkansas|
|Arkansas Cardiology, PA|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Eric Topol, M.D.||Scripps Translational Science Institute, La Jolla, CA USA|
|Principal Investigator:||Robert Kowal, M.D.,Ph.D.||HeartPlace Baylor, Dallas, TX USA|