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Coronary RestenosisNCT00589810

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

An observational study of Coronary Restenosis, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Restenosis
How many people
761 participants
Where
1 siteUnited States
Study dates
Aug 2007to Nov 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Read the 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.

Keywords
ISR, in-stent restenosis, restenosis, BMS, bare metal stent, revascularization, genetic, cardiac catheterization
Medical subject headings
Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00589810
Study groupRoleWhat they receive
ControlsControls = 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.
CasesCases = 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent restenosis

    Measured: 1 year

Secondary outcomes (3)

  1. Target vessel revascularization

    Measured: 1 year

  2. Positive stress test

    Measured: 1 year

  3. Negative cardiac catheterization

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionNov 2010
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
761 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00589810
Sponsor's protocol ID
06-887
Status last verified
Mar 2017
First submitted
26 Dec 2007
Last updated
24 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31. doi: 10.1056/NEJMoa032441.

    PubMed 14724301

  • Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and intravascular ultrasound follow-up. Circulation. 2001 Oct 23;104(17):2007-11. doi: 10.1161/hc4201.098056.

    PubMed 11673337

  • Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001 Jan 16;103(2):192-5. doi: 10.1161/01.cir.103.2.192.

    PubMed 11208675

  • Schaid DJ. Power and sample size for testing associations of haplotypes with complex traits. Ann Hum Genet. 2006 Jan;70(Pt 1):116-30. doi: 10.1111/j.1529-8817.2005.00215.x.

    PubMed 16441261

  • Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.

    PubMed 14523139

  • Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

    PubMed 12050336

  • Lowe HC, Oesterle SN, Khachigian LM. Coronary in-stent restenosis: current status and future strategies. J Am Coll Cardiol. 2002 Jan 16;39(2):183-93. doi: 10.1016/s0735-1097(01)01742-9.

    PubMed 11788206

  • Kastrati A, Schomig A, Elezi S, Schuhlen H, Dirschinger J, Hadamitzky M, Wehinger A, Hausleiter J, Walter H, Neumann FJ. Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol. 1997 Nov 15;30(6):1428-36. doi: 10.1016/s0735-1097(97)00334-3.

    PubMed 9362398

  • Ganesh SK, Skelding KA, Mehta L, O'Neill K, Joo J, Zheng G, Goldstein J, Simari R, Billings E, Geller NL, Holmes D, O'Neill WW, Nabel EG. Rationale and study design of the CardioGene Study: genomics of in-stent restenosis. Pharmacogenomics. 2004 Oct;5(7):952-1004. doi: 10.1517/14622416.5.7.949.

    PubMed 15469413

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Restenosis, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent restenosis (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00589810, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.

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