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Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00379418
First received: September 19, 2006
Last updated: September 20, 2006
Last verified: September 2006
History of Changes
  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 Phase
Coronary Artery Disease
 Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Estimated Enrollment: 220
Study Start Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 antagonistwithin 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379418

Contacts
Contact: Tanuj K Kamineni 404 712 0168 tkamine@emory.edu
Contact: Johnson Pereira, MD 404 712 0168 jpereir@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tanuj K Kamineni     404-712-0168     tkamine@meory.edu    
Contact: Johnson Pereira, MD     404-712-0168     jpereir@emory.edu    
Atlanta VA Medical Center Recruiting
Atlanta, Georgia, United States, 30033
Contact: Kreton Mavromatis, MD     404-329-2207     kmavro@emory.edu    
Contact: Padi K Reddy     4043216111 ext 6223        
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Arshed A Quyyumi, M.D. EUH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00379418     History of Changes
Other Study ID Numbers: 812-2002
Study First Received: September 19, 2006
Last Updated: September 20, 2006
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

ClinicalTrials.gov processed this record on May 19, 2013