Clinical trial NCT00626145: Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI
Official title: Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Keywords: BMMNC
STEMI
stem cell
intracoronary delivery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 37
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Left Ventricular Ejection Fraction(LVEF)
timeFrame: 1, 3, 6 months, 1, 4 years
Secondary outcomes:
measure: in-stent restenosis
timeFrame: 1, 3, 6 months, 1, 4 years
measure: cardiac shock
timeFrame: 1, 3, 6 months, 1, 4 years
measure: myocardial viability of the infarcted area
timeFrame: 1, 3, 6 months, 1, 4 years
measure: end-diastolic Volume/end-systolic Volume(EDV/ESV)
timeFrame: 1, 3, 6 months, 1, 4 years
measure: wall motion score index(WMSI)
timeFrame: 1, 3, 6 months, 1, 4 years
measure: cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)
timeFrame: 1, 3, 6 months, 1, 4 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiology in Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Haichang Wang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: