Overview

This trial is active, not recruiting.

Condition myocardial infarction
Treatments saline infusion, autologous bone marrow mononuclear cells infusion
Phase phase 1/phase 2
Sponsor Xijing Hospital
Start date March 2003
End date March 2008
Trial size 37 participants
Trial identifier NCT00626145, 00200301

Summary

The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
Patients receive intracoronary injections of saline 7 days after PCI.
saline infusion saline placebo
Patients receive intracoronary injections of saline 7 days after PCI.
(Experimental)
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
autologous bone marrow mononuclear cells infusion autologous BMMC infusion
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.

Primary Outcomes

Measure
Left Ventricular Ejection Fraction(LVEF)
time frame: 1, 3, 6 months, 1, 4 years

Secondary Outcomes

Measure
in-stent restenosis
time frame: 1, 3, 6 months, 1, 4 years
cardiac shock
time frame: 1, 3, 6 months, 1, 4 years
myocardial viability of the infarcted area
time frame: 1, 3, 6 months, 1, 4 years
end-diastolic Volume/end-systolic Volume(EDV/ESV)
time frame: 1, 3, 6 months, 1, 4 years
wall motion score index(WMSI)
time frame: 1, 3, 6 months, 1, 4 years
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)
time frame: 1, 3, 6 months, 1, 4 years

Eligibility Criteria

Male or female participants from 45 years up to 65 years old.

Inclusion Criteria: - ST segment elevation myocardial infarction, according to the WHO definition. - <24 hour from the origin of symptoms. - Single left anterior descending coronary artery disease. - Successful revascularization of culprit lesion with PCI. - Age between 45 and 65 years old. - Written informed consent. Exclusion Criteria: - Previous MI. - Cardiomyopathy. - Atrial fibrillation or fluctuation. - Previous heart surgery. - Severe valvular heart disease. - Disease of the hematopoetic system. - NYHA functional class IV at baseline. - Severe renal, lung and liver disease or cancer. - Significant coronary lesion in one or more major coronary vessels, requiring revascularization. - Intra-cardiac thrombus.

Additional Information

Official title Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
Principal investigator Haichang Wang, MD,PHD
Description The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Xijing Hospital.