NIH Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal
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In this replication study at the Cleveland Clinic, we seek to collaborate to validate findings of the CardioGene Study in an independent cohort of patients who have undergone bare metallic stenting.
Condition |
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Coronary Restenosis |
Study Type: | Observational |
Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
Official Title: | NIH Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal |
- In-stent restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Target vessel revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Positive stress test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Negative cardiac catheterization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
DNA
Estimated Enrollment: | 500 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | April 2008 |
Groups/Cohorts |
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Controls
Controls = Patients in Genebank that had BMS placed that did not go on to have ISR within 1 year of BMS placement and have not had prior ISR in any vessel ever. If testing is available, the Control status will be further verified by angiographic documentation of <50% luminal loss with the stent or negative stress test six or more months after stenting.
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Cases
Cases = Patients in Genebank that had BMS placed that went on to have ISR which is defined as PCI or CABG to the Target Vessel within 1 year of the BMS placement.
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Detailed Description:
Dr. Elizabeth Nabel, Dr. Santhi K. Ganesh and colleagues at the National Institutes of Health have completed a genetic association study, entitled the CardioGene Study, using 100,000 SNPs spanning the entire human genome in subjects with restenosis after percutaneous intervention using bare metallic stents (Ganesh SK, 2004). In this replication study at the Cleveland Clinic, we seek to collaborate to validate findings of the CardioGene Study in an independent cohort of patients who have undergone bare metallic stenting. This study will examine samples and clinical data collected of subjects undergoing cardiac catheterization who meet study criteria, selected from the GeneBank. In the Genebank repository, subjects are informed their samples may be used indefinitely for study and consent to having their data/samples shared with other investigators at the Cleveland Clinic or other collaborating institutions. No information that might identify subjects is shared with collaborating investigators and samples will be shared in a de-identified manner, using assigned study numbers.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Cleveland Clinic patients already enrolled in the GeneBank study who have had left heart catheterization and bare metal stenting
Inclusion Criteria:
- Age >18 with informed consent for participation in Genetics Research
- BMS placed in a de novo(previously untreated by any type of PCI) lesion within a native coronary artery (not within a bypass graft) lesion
- Outcome data available at 12 months
Exclusion Criteria:
For both cases and controls:
- Age less than 18
- No informed consent for Genetic Research
- BMS placed in a bypass graft.
- Radiation to the same lesion treated with bare metal stent at the time of index stenting (continued on next page)
- A drug-eluting stent within or overlapping the target lesion BMS placed at the time index stenting.
Participation in a cardiovascular study at any time between index stenting procedure and day 365 post stenting or until TVR, which ever occurs first, which meets one or more of the following:
- Placebo vs an active drug being studied against restenosis rates, atheroma volume or thrombosis, in which unblinding information is not available and the study results are unknown or the active drug is shown to have a positive effect.
- Placebo vs active drug known to have an effect on restenosis rates, atheroma volume or thrombosis in which unblinding information is not available.
- Blinded randomized studies involving two classes of drug in which the results are unknown or the results of the study show superiority to one of the treatment arms and unblinding information is not available.
For controls only: in addition to the exclusions above:
- any prior history of TVR(TRRS)
- positive stress test or cath with > or equal to 50% stenosis of target lesion within one year of index bare metal stenting.
- Subjects reported to be deceased in the Interventional Registry or through chart abstraction without negative cath results or negative stress test results between 5 months and 13 months post index procedure.
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Publications:
Responsible Party: | Dr. Stephen Ellis, MD, Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00589810 History of Changes |
Other Study ID Numbers: | NHLBI-PB-HG-2007-064-KLW, NHLBI-PB-HG-2007-064-KLW6, CardioGene, IRB06-887 |
Study First Received: | December 26, 2007 |
Last Updated: | December 26, 2007 |
Health Authority: | United States: Federal Government |
Keywords provided by The Cleveland Clinic:
ISR in-stent restenosis restenosis BMS |
bare metal stent revascularization genetic cardiac catheterization |
Additional relevant MeSH terms:
Coronary Restenosis Coronary Stenosis Coronary Disease Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on October 17, 2012