Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test (EXERCISE)
This study is currently recruiting participants.
Verified February 2013 by CardioDx
Sponsor:
CardioDx
Information provided by (Responsible Party):
CardioDx
ClinicalTrials.gov Identifier:
NCT01486030
First received: October 17, 2011
Last updated: February 7, 2013
Last verified: February 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 17, 2011 | ||||
| Last Updated Date | February 7, 2013 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Gene expression score difference between peak exercise and baseline [ Time Frame: up to 1 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01486030 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test | ||||
| Official Title ICMJE | Effect of Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test | ||||
| Brief Summary | Acute exercise such as in exercise stress test would affect the peripheral gene expression levels of the 23 genes in the CORUS CAD algorithm and the time frame. |
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| Detailed Description | Pilot study, investigates the effects of "acute" exercise on PGE levels as measured by CORUS CAD score. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: RNA PAXgene |
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| Sampling Method | Probability Sample | ||||
| Study Population | Acute exercise, exercise stress test affect the peripheral gene expression levels of the 23 genes in the CORUS CAD algorithm and the time frame at which, gene levels change. |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01486030 | ||||
| Other Study ID Numbers ICMJE | CDX_000012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | CardioDx | ||||
| Study Sponsor ICMJE | CardioDx | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | CardioDx | ||||
| Verification Date | February 2013 | ||||
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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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