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Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
This study has been completed.
Study NCT00664807   Information provided by Medtronic Corporate Technologies and New Ventures
First Received: April 21, 2008   Last Updated: August 24, 2009   History of Changes

April 21, 2008
August 24, 2009
April 2008
April 2009   (final data collection date for primary outcome measure)
Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00664807 on ClinicalTrials.gov Archive Site
  • Positive predictive value of genetic markers as predictors of life-threatening arrhythmias. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Association between risk factors identified in the CRF and life-threatening arrhythmias. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Correlation of SNPs to other co-morbidities identified in the CRF information. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Association between ECG-based risk markers and life-threatening arrhythmias. [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
 
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
Medtronic Genetic Arrhythmia Markers for Early Detection

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.

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.
Phase IV
Observational
Case Control, Prospective
  • Death, Sudden, Cardiac
  • Ventricular Fibrillation
  • Tachycardia
  • Atrial Fibrillation
  • Sick Sinus Syndrome
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1023
May 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

The following criteria apply to all subjects:

  • Subject has an ICD or CRT ICD implanted
  • Subject must be on optimal medical therapy
  • Subject is a Caucasian with all 4 grandparents believed to be Caucasian
  • Subject has had a myocardial infarction (MI) prior to ICD implantation
  • Subject is willing and able to comply with the study protocol
  • Subject is willing and able to sign and date the study Informed Consent and HIPAA Authorization (US)

Case Inclusion Criteria:

The following criteria apply to case subjects only:

  • Subject is at least 40 years of age at time of ICD implantation
  • 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.

Control Inclusion Criteria:

The following criteria apply to control subjects only:

  • Subject is currently at least 70 years of age
  • Subject has haad currently implanted Medronic ICD for a minimum of three years

Exclusion Criteria:

The following criteria apply to all subjects:

  • Subject has received a bone marrow or heart transplant at any time
  • Subject has a previously identified cause for arrhythmias (Brugada, LQT, HCM)

Control Exclusion Criteria:

The following criteria apply to control subjects only:

  • Subject has had a potentially LTA documented on their ICD
  • Subject was previously identified as having a LTD at any time in life
  • Subject has had the memory on their ICD cleared at any time in the past three years.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00664807
Tara Nahey/Senior Scientist, Medtronic Corporate Technologies and New Ventures
MDT-CTNV-001
Medtronic Corporate Technologies and New Ventures
 
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
Medtronic Corporate Technologies and New Ventures
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP