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Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study) (GAME)

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ClinicalTrials.gov Identifier: NCT00664807
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Medtronic Corporate Technologies and New Ventures

Tracking Information
First Submitted Date April 21, 2008
First Posted Date April 23, 2008
Last Update Posted Date August 25, 2009
Study Start Date April 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2008)
Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias. [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00664807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 21, 2008)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
Official Title Medtronic Genetic Arrhythmia Markers for Early Detection
Brief 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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary Care Clinic, Hospitals
Condition
  • Death, Sudden, Cardiac
  • Ventricular Fibrillation
  • Tachycardia
  • Atrial Fibrillation
  • Sick Sinus Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Murray SS, Smith EN, Villarasa N, Nahey T, Lande J, Goldberg H, Shaw M, Rosenthal L, Ramza B, Alaeddini J, Han X, Damani S, Soykan O, Kowal RC, Topol EJ; GAME Investigators. Genome-wide association of implantable cardioverter-defibrillator activation with life-threatening arrhythmias. PLoS One. 2012;7(1):e25387. doi: 10.1371/journal.pone.0025387. Epub 2012 Jan 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 24, 2009)
1023
Original Estimated Enrollment
 (submitted: April 21, 2008)
1000
Actual Study Completion Date May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00664807
Other Study ID Numbers MDT-CTNV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tara Nahey/Senior Scientist, Medtronic Corporate Technologies and New Ventures
Study Sponsor Medtronic Corporate Technologies and New Ventures
Collaborators Not Provided
Investigators
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
PRS Account Medtronic Corporate Technologies and New Ventures
Verification Date August 2009