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Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379418
First Posted: September 21, 2006
Last Update Posted: September 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kreton Mavromatis, MD, FACC, Emory University
  Purpose

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 Intervention Phase
Coronary Artery Disease Drug: Abciximab Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)

Resource links provided by NLM:


Further study details as provided by Kreton Mavromatis, MD, FACC, Emory University:

Enrollment: 220
Study Start Date: January 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Abciximab
    Other Name: Reopro
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with coronary artery disease undergoing left heart catheterization
Criteria

Inclusion Criteria:

  1. Have either:

    • clinical history of anginal symptoms or positive stress test or
    • in stent restenosis
  2. Have an angiographic >70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure
  3. For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose
  4. negative pregnancy test
  5. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379418


Locations
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30033
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Arshed A Quyyumi, M.D. EUH
  More Information

Responsible Party: Kreton Mavromatis, MD, FACC, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00379418     History of Changes
Other Study ID Numbers: IRB00021864
First Submitted: September 19, 2006
First Posted: September 21, 2006
Last Update Posted: September 12, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Abciximab
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Anticoagulants
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs