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:

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Abciximab

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30033
      • Atlanta VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease undergoing left heart catheterization

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Arshed A Quyyumi, M.D., EUH

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 19, 2006
• First Submitted That Met QC Criteria: September 20, 2006
• First Posted (Estimate): September 21, 2006

Study Record Updates

• Last Update Posted (Estimate): September 12, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Platelet Aggregation Inhibitors; Anticoagulants; Abciximab
• Other Study ID Numbers: IRB00021864