Trials / Completed
CompletedNCT00664807
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
Medtronic Genetic Arrhythmia Markers for Early Detection
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,023 (actual)
- Sponsor
- Medtronic Corporate Technologies and New Ventures · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. 1. to identify genes associated with SCD susceptibility. 2. to identify risk factors associated with SCD as found in the case report form (CRF). 3. to correlate SNPs with co-morbidities in the subjects as found in the CRF information. 4. to study the association between parameters derived from Holter recordings and predictors of life-threatening arrhythmias.
Conditions
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-04-01
- Completion
- 2009-05-01
- First posted
- 2008-04-23
- Last updated
- 2009-08-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00664807. Inclusion in this directory is not an endorsement.