- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379418
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)
AIR STUDY
TITLE: Anti-Ischemic effects of Abciximab(Reopro)
PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).
INTERVENTION: Heparin vs. heparin + abciximab during PCI
PURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow.
PATIENT ASSESSMENT:
- 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.
- Measurement of blood flow in selected suitable patients
- 10 minute questionnaire before discharge and on visit on day 28.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Have either:
- clinical history of anginal symptoms or positive stress test or
- in stent restenosis
- Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure
- For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose
- negative pregnancy test
- are able to give informed consent
Exclusion Criteria:
- Coronary intervention within four weeks prior to enrollment.
- Treatment with abciximab antagonist within four weeks.
- treatment with thrombolytic therapy within 48 hours
- MI within 2 months.
- recent infections
- general anesthesia within 3 months.
- renal failure
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arshed A Quyyumi, M.D., EUH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00021864
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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