Stem Cell Therapy as Adjunct to Revascularization

Withdrawn before enrolling · Phase 1

Conditions studied: Coronary Arteriosclerosis, Coronary Artery Bypass Graft, Myocardial Revascularization

In brief

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 (CABG).

Key facts

Study ID

NCT00463853

Run by

US Department of Veterans Affairs

People needed

0

Starts

2007-08-01

Expected to finish

2009-10-01

Last updated by the study team

2014-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Salt Lake City Health Care System, Salt Lake City — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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