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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: The Cleveland Clinic

Current Primary Outcome: In-stent restenosis [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Target vessel revascularization [ Time Frame: 1 year ]
  • Positive stress test [ Time Frame: 1 year ]
  • Negative cardiac catheterization [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: December 26, 2007
Date Started: August 2007
Date Completion:
Last Updated: March 22, 2017
Last Verified: March 2017