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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00589810
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 26, 2007
December 26, 2007
August 2007
Not Provided
In-stent restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
NIH Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal
NIH 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.
 
Enrolling by invitation
500
April 2008
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589810
NHLBI-PB-HG-2007-064-KLW, NHLBI-PB-HG-2007-064-KLW6, CardioGene, IRB06-887
No
Dr. Stephen Ellis, MD, Cleveland Clinic
The Cleveland Clinic
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephen Ellis, MD The Cleveland Clinic
The Cleveland Clinic
December 2007

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