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Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen G. Ellis, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00589810
First received: December 26, 2007
Last updated: March 22, 2017
Last verified: March 2017

December 26, 2007
March 22, 2017
August 2007
November 2010   (Final data collection date for primary outcome measure)
In-stent restenosis [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00589810 on ClinicalTrials.gov Archive Site
  • Target vessel revascularization [ Time Frame: 1 year ]
  • Positive stress test [ Time Frame: 1 year ]
  • Negative cardiac catheterization [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal
Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal
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.
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.
Observational
Observational Model: Case-Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
DNA
Non-Probability Sample
Cleveland Clinic patients already enrolled in the GeneBank study who have had left heart catheterization and bare metal stenting
Coronary Restenosis
Not Provided
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
761
November 2011
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00589810
06-887
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Stephen G. Ellis, M.D., The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Stephen Ellis, MD The Cleveland Clinic
The Cleveland Clinic
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP