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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
September 19, 2006
September 21, 2006
September 12, 2013
January 2003
December 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00379418 on ClinicalTrials.gov Archive Site
Not Provided
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Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects with coronary artery disease undergoing left heart catheterization
Coronary Artery Disease
Drug: Abciximab
Other Name: Reopro
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00379418
IRB00021864
No
Not Provided
Not Provided
Kreton Mavromatis, MD, FACC, Emory University
Emory University
Not Provided
Principal Investigator: Arshed A Quyyumi, M.D. EUH
Emory University
September 2013