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

March 22, 2017 updated by: Stephen G. Ellis, M.D., The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

761

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cleveland Clinic patients already enrolled in the GeneBank study who have had left heart catheterization and bare metal stenting

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-stent restenosis
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Target vessel revascularization
Time Frame: 1 year
1 year
Positive stress test
Time Frame: 1 year
1 year
Negative cardiac catheterization
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Stephen Ellis, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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