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.
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
- 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
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
- 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.