Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study) - Full Text View

Sponsored by:	Medtronic Corporate Technologies and New Ventures
Information provided by:	Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier:	NCT00664807

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 IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Cardiac Arrest

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated 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.

to identify genes associated with SCD susceptibility.
to identify risk factors associated with SCD as found in the case report form (CRF).
to correlate SNPs with co-morbidities in the subjects as found in the CRF information.
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 a Medtronic 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

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

Contacts

Contact: Orhan Soykan, Ph.D.	763-505-4518	orhan.soykan@medtronic.com
Contact: Tara L Nahey, DVM, Ph.D.	763-505-4599	tara.l.nahey@medtronic.com

Locations

United States, Arkansas
Arkansas Cardiology, PA	Recruiting
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

Responsible Party:	Medtronic Corporate Technologies and New Ventures ( Tara Nahey/Senior Scientist )
Study ID Numbers:	MDT-CTNV-001
Study First Received:	April 21, 2008
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00664807
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Death
Heart Diseases
Tachycardia
Arrhythmia, Sinus
Heart Arrest
Heart Block
Death, Sudden

Paroxysmal ventricular fibrillation
Death, Sudden, Cardiac
Atrial Fibrillation
Sick Sinus Syndrome
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Disease
Pathologic Processes
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009