Acute Myocardial Infarction, Heart Failure
Conditions
Keywords
Magnetic resonance Imaging
Brief summary
The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.
Interventions
BIOLOGICALIntracoronary delivery of unfractionated bone marrow mononuclear cells
Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
BIOLOGICALPlacebo
Plasma and culture medium (10 ml)
Sponsors
Duke Clinical Research Institute
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age and no more than 80 years of age. * Acute ST-segment elevation MI * Symptoms suggestive of acute MI * ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block * Time from symptom onset to enrollment \< 120 hours * Left ventricular dysfunction by contrast ventriculography or echocardiography * EF above 25 % and lower than 40% * Focal wall motion akinesis or dyskinesis * Clearly identifiable infarct artery * Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement
Exclusion criteria
* Planned treatment with bypass surgery or prior CABG * Multi-vessel PCI * Prior myocardial infarction by history or presence of pathologic Q-waves * Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes * Successful reperfusion \< 3 hrs from symptom onset * Prior MI or significant chronic heart failure * Pacemaker/defibrillator * Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat) * Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance\<25 and/or serum Cr \>2.5 mg/dl) * Baseline hematocrit \< 30 * Pregnancy, or lactation/parturition within the past 30 days * Active or planned treatment with chemotherapy * Anticipated difficulty with 90-day follow-up * Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive * Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial * Previous enrollment in this trial * Participation in an investigational drug or device study within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients | baseline and 90 days |
| Occurence of arrhythmia, heart failure and death | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in regional left ventricular function | 90 days |
Outcome results
None listed