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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
  Purpose

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
Coronary Restenosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: NIH Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • In-stent restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

DNA


Estimated Enrollment: 500
Study Start Date: August 2007
Estimated Study Completion Date: April 2008
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589810

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Stephen Ellis, MD The Cleveland Clinic
  More Information

Publications:

Responsible Party: Dr. Stephen Ellis, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00589810     History of Changes
Other Study ID Numbers: NHLBI-PB-HG-2007-064-KLW, NHLBI-PB-HG-2007-064-KLW6, CardioGene, IRB06-887
Study First Received: December 26, 2007
Last Updated: December 26, 2007
Health Authority: United States: Federal Government

Keywords provided by The Cleveland Clinic:
ISR
in-stent restenosis
restenosis
BMS
bare metal stent
revascularization
genetic
cardiac catheterization

Additional relevant MeSH terms:
Coronary Restenosis
Cardiovascular Diseases
Coronary Disease
Coronary Stenosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014