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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kreton Mavromatis, MD, FACC, Emory University
ClinicalTrials.gov Identifier:
NCT00379418
First received: September 19, 2006
Last updated: September 11, 2013
Last verified: September 2013
  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 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379418

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

No publications provided

Responsible Party: Kreton Mavromatis, MD, FACC, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00379418     History of Changes
Other Study ID Numbers: IRB00021864
Study First Received: September 19, 2006
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014