Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)

NCT00664807 | Completed

• 1 other identifier: MDT-CTNV-001
• Study Type: observational
• Target: 1,023
• Locations: 1 country
• Sites: 1

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.

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia; Atrial Fibrillation; Sick Sinus Syndrome

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (4)

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

  one year

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

  one year

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

  one year

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

  one year

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic, Hospitals

You may qualify if:

• 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)
• 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.
• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Medtronic Corporate Technologies and New Ventures: lead

Study Sites (1)

Arkansas Cardiology, PA

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 22247754 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia; Atrial Fibrillation; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

US (1)