Clincosm LogoSign in Get a demo

AIR: Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT00379418
Collaborator
(none)
220
Enrollment
2
Locations
83
Duration (Months)
110
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

  1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.

  2. Measurement of blood flow in selected suitable patients

  3. 10 minute questionnaire before discharge and on visit on day 28.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
220 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Have either:

    • clinical history of anginal symptoms or positive stress test or

    • in stent restenosis

    1. Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure

    2. For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose

    3. negative pregnancy test

    4. are able to give informed consent

    Exclusion Criteria:

    1. Coronary intervention within four weeks prior to enrollment.

    2. Treatment with abciximab antagonist within four weeks.

    3. treatment with thrombolytic therapy within 48 hours

    4. MI within 2 months.

    5. recent infections

    6. general anesthesia within 3 months.

    7. renal failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atlanta VA Medical Center Atlanta Georgia United States 30033
    2 Emory University Hospital Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Arshed A Quyyumi, M.D., EUH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kreton Mavromatis, MD, FACC, Assistant Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT00379418
    Other Study ID Numbers:
    • IRB00021864
    First Posted:
    Sep 21, 2006
    Last Update Posted:
    Sep 12, 2013
    Last Verified:
    Sep 1, 2013
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Abciximab

    Study Results

    No Results Posted as of Sep 12, 2013