Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

NCT00379418 | Completed

• 1 other identifier: IRB00021864
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 2

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. 1.50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.
2. 2.Measurement of blood flow in selected suitable patients
3. 3.10 minute questionnaire before discharge and on visit on day 28.

Conditions

Coronary Artery Disease

Interventions

Abciximab DRUG

Also known as: Reopro

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease undergoing left heart catheterization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Arshed A Quyyumi, M.D.

  EUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: January 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (2)