Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction
- Conditions
- Myocardial Infarction
- Interventions
- Other: BMC therapy within 3-7 daysOther: PCI onlyOther: BMC therapy within 24 hoursOther: BMC therapy within 7-30 days
- Registration Number
- NCT02425358
- Lead Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Brief Summary
Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).
- Detailed Description
On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- a history of first acute ST-elevation myocardial infarction
- treatment with successful PCI two to twelve hours after symptom onset
- LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI
- previous Q-wave myocardial infarction
- cardiogenic shock
- severe coexisting conditions such as acute and chronic heart failure, malignant
- arrhythmia, renal failure and severe bleeding that interfered with the ability of the
- patient to comply with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMC therapy within 3-7 days BMC therapy within 3-7 days Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI. PCI only PCI only Patients with acute myocardial infarction who were performed successful primary PCI. BMC therapy within 24 hours BMC therapy within 24 hours Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI. BMC therapy within 7-30 days BMC therapy within 7-30 days Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI.
- Primary Outcome Measures
Name Time Method Change of left ventricular eject factor (LVEF) from the baseline 12 months
- Secondary Outcome Measures
Name Time Method Change of left ventricular end-diastolic volume (LVESV) from the baseline 12 months Change of left ventricular end-systolic volume (LVEDV) from the baseline 12 months Change of myocardial perfusion from the baseline 12 months