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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00589810

Collaborator

(none)

761

Enrollment

Location

Actual Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Restenosis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

761 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

In-stent restenosis [1 year]

Secondary Outcome Measures

Target vessel revascularization [1 year]
Positive stress test [1 year]
Negative cardiac catheterization [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.