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Sponsors and Collaborators: |
The Cleveland Clinic National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00589810 |
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: | Case Control, Retrospective |
Official Title: | NIH Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal |
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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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.
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:
Exclusion Criteria:
For both cases and controls:
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:
For controls only: in addition to the exclusions above:
Responsible Party: | Cleveland Clinic ( Dr. Stephen Ellis, MD ) |
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 |
ClinicalTrials.gov Identifier: | NCT00589810 |
Health Authority: | United States: Federal Government |
ISR in-stent restenosis restenosis BMS |
bare metal stent revascularization genetic cardiac catheterization |
Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Constriction, Pathologic |
Ischemia Coronary Stenosis Coronary Restenosis Coronary Artery Disease |
Cardiovascular Diseases |