Death, Sudden, CardiacGAMENCT00664807
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
An observational study of Death, Sudden, Cardiac and Ventricular Fibrillation, run by Medtronic Corporate Technologies and New Ventures at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia
- How many people
- 1,023 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic, Hospitals
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Cardiology, PA
Little Rock, Arkansas, 72205
About this study
Official title: Medtronic Genetic Arrhythmia Markers for Early Detection
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.
- 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.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias.
Measured: one year
Secondary outcomes (4)
Positive predictive value of genetic markers as predictors of life-threatening arrhythmias.
Measured: one year
Association between risk factors identified in the CRF and life-threatening arrhythmias.
Measured: one year
Correlation of SNPs to other co-morbidities identified in the CRF information.
Measured: one year
Association between ECG-based risk markers and life-threatening arrhythmias.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Corporate Technologies and New Ventures
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Topol, M.D., Principal investigator, Scripps Translational Science Institute, La Jolla, CA USARobert Kowal, M.D.,Ph.D., Principal investigator, HeartPlace Baylor, Dallas, TX USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664807
- Sponsor's protocol ID
- MDT-CTNV-001
- Acronym
- GAME
- Status last verified
- Aug 2009
- First submitted
- 21 Apr 2008
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Genetic Arrhythmia Markers for Early Detection
- ClinicalTrials.gov ID
- NCT00664807
- Acronym / sponsor ID
- GAME / MDT-CTNV-001
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation, Sick Sinus Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Medtronic Corporate Technologies and New VenturesIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic, Hospitals
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (8 listed)
- Subject has received a bone marrow or heart transplant at any time
- Subject has a previously identified cause for arrhythmias (Brugada, LQT, HCM)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias.
Time frame: one year
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Derived from this study: PubMed 22247754Murray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, Sudden, Cardiac and Ventricular Fibrillation, run by Medtronic Corporate Technologies and New Ventures at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.