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

Completed

Conditions studied: Coronary Restenosis

In brief

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.

Key facts

Study ID

NCT00589810

Run by

The Cleveland Clinic

People needed

761

Starts

2007-08-01

Expected to finish

2011-11-01

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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