Status:
WITHDRAWN
Stem Cell Therapy as Adjunct to Revascularization
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
University of Utah
Conditions:
Coronary Arteriosclerosis
Coronary Artery Bypass Graft
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether it is safe to receive an injection of your own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary artery bypass graft...
Detailed Description
The experimental design will be a Phase I safety trial in which all subjects from the VA Salt Lake City Health Care System presenting with CAD and associated depressed LV function requiring myocardial...
Eligibility Criteria
Inclusion
- Veteran
- Age 18 or older
- Ability to give informed consent
- Have documented CAD and depressed LV function (EF \<40%) that is felt to be appropriately treated with surgical revascularization by the VA Salt Lake City Health Care System Cardiothoracic Surgery team and in accordance with the published 2004 ACC/AHA Guideline Update for Coronary Artery Bypass Graft Surgery; specifically, in accordance with the described indication for CABG in patients with Poor LV Function (see below).
- Class I
- CABG should be performed in patients with poor LV function who have significant left main coronary artery stenosis. (Level of Evidence: B)
- CABG should be performed in patients with poor LV function who have left main equivalent:
- significant (greater than or equal to 70%) stenosis of the proximal LAD and proximal left circumflex artery. (Level of Evidence: B)
- CABG should be performed in patients with poor LV function who have proximal LAD stenosis with 2- or 3-vessel disease. (Level of Evidence: B)
- Class IIa
- CABG may be performed in patients with poor LV function with significant viable noncontracting, revascularizable myocardium and without any of the above anatomic patterns. (Level of Evidence: B)
- NHYA/CCA Class I or higher
- Abnormal cardiac wall segment on preoperative data
- Acutely stable myocardium without evidence of cardiogenic shock or evolving myocardial infarction
Exclusion
- EF 40%
- CAD not amenable to CABG
- ACC/AHA Poor LV Function Class III - CABG should not be performed in patients with poor LV function without evidence of intermittent ischemia and without evidence of significant revascularizable viable myocardium. (Level of Evidence: B) Evidence of intermittent ischemia is defined clinically by Cardiovascular Disease Classification (see chart above). Objectively, this can be demonstrated by various modalities that can demonstrate ischemic myocardium. Such modalities include SCA, Echo, CMRI, and radionucleotide imaging.
- Patients undergoing cardiac re-operation
- Patients with operable valvular disease
- Patients with preexisting malignant arrhythmia
- Patients with preexisting systemic malignancy
- Patients with a contraindication to MRI
- Presence of ongoing local or systemic infection
- Participation in another clinical trial
- Emergency operation
- Preoperative cardiogenic shock or evolving myocardial infarction
- ASA Class V or contraindication to general anesthesia
- Pregnancy
- Prisoner
- Active history of alcohol or substance abuse
- Active psychiatric history leading to potential for poor study participation and follow-up
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00463853
Start Date
August 1 2007
End Date
October 1 2009
Last Update
June 11 2014
Active Locations (1)
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1
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148