Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)

This study has been completed.
Sponsor:
Information provided by:
Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier:
NCT00664807
First received: April 21, 2008
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

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 Phase
Death, Sudden, Cardiac
Ventricular Fibrillation
Tachycardia
Atrial Fibrillation
Sick Sinus Syndrome
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Medtronic Genetic Arrhythmia Markers for Early Detection

Resource links provided by NLM:


Further study details as provided by Medtronic Corporate Technologies and New Ventures:

Primary Outcome Measures:
  • Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1023
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic, Hospitals

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664807

Locations
United States, Arkansas
Arkansas Cardiology, PA
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Medtronic Corporate Technologies and New Ventures
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
  More Information

No publications provided by Medtronic Corporate Technologies and New Ventures

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tara Nahey/Senior Scientist, Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT00664807     History of Changes
Other Study ID Numbers: MDT-CTNV-001
Study First Received: April 21, 2008
Last Updated: August 24, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Sick Sinus Syndrome
Tachycardia
Ventricular Fibrillation
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiovascular Diseases
Death
Heart Arrest
Heart Block
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014