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CompletedNCT00664807GAMEUpdated Aug 25, 2009

Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)

An observational study in Death, Sudden, Cardiac, Ventricular Fibrillation and Tachycardia, sponsored by Medtronic Corporate Technologies and New Ventures. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by Medtronic Corporate Technologies and New Ventures (part of Medtronic) · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,023
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Death, Sudden, Cardiac
  • Ventricular Fibrillation
  • Tachycardia
  • Atrial Fibrillation
  • Sick Sinus Syndrome
03

In context

Death, Sudden, Cardiac

322 studies on the registry are indexed under Death, Sudden, Cardiac; 81 are open to participants now.

This study's enrollment of 1,023 is above the median of 500 across 177 observational studies indexed under Death, Sudden, Cardiac.

Browse Death, Sudden, Cardiac studies →

Lead sponsor

Medtronic Corporate Technologies and New Ventures is the lead sponsor of 4 studies on the registry; none are open to participants now.

Browse Medtronic Corporate Technologies and New Ventures studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary Care Clinic, Hospitals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,023 participants (actual)
06

What researchers measure

Primary outcomes

  1. Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias.

    Time frame: one year

Secondary outcomes

  1. Positive predictive value of genetic markers as predictors of life-threatening arrhythmias.

    Time frame: one year

  2. Association between risk factors identified in the CRF and life-threatening arrhythmias.

    Time frame: one year

  3. Correlation of SNPs to other co-morbidities identified in the CRF information.

    Time frame: one year

  4. Association between ECG-based risk markers and life-threatening arrhythmias.

    Time frame: one year

07

Study locations

1 site
  • Arkansas Cardiology, PA
    Little Rock, Arkansas 72205, United States
08

References and documents

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. PubMed 22247754 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00664807
Lead sponsor
Medtronic Corporate Technologies and New Ventures
First posted
Apr 23, 2008
Start date
Apr 2008
Primary completion
Apr 2009
Completion
May 2009
Last update
Aug 25, 2009

Study contacts

Eric Topol, M.D.
principal investigator · Scripps Translational Science Institute, La Jolla, CA USA
Robert Kowal, M.D.,Ph.D.
principal investigator · HeartPlace Baylor, Dallas, TX USA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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