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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 21, 2008 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | April 2008 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Positive predictive value of single nucleotide polymorphisms as predictors of life-threatening arrhythmias. [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00664807 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study) | ||||||||
| Official Title ICMJE | Medtronic Genetic Arrhythmia Markers for Early Detection | ||||||||
| 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. |
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| 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.
The secondary objectives involve more detailed analysis to search for potentially unidentified genetic markers of risk for SCD.
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 1023 | ||||||||
| Completion Date | May 2009 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: The following criteria apply to all subjects:
Case Inclusion Criteria: The following criteria apply to case subjects only:
Control Inclusion Criteria: The following criteria apply to control subjects only:
Exclusion Criteria: The following criteria apply to all subjects:
Control Exclusion Criteria: The following criteria apply to control subjects only:
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| Gender | Both | ||||||||
| Ages | 40 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00664807 | ||||||||
| Responsible Party | Tara Nahey/Senior Scientist, Medtronic Corporate Technologies and New Ventures | ||||||||
| Study ID Numbers ICMJE | MDT-CTNV-001 | ||||||||
| Study Sponsor ICMJE | Medtronic Corporate Technologies and New Ventures | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Medtronic Corporate Technologies and New Ventures | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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