Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI
Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFebruary 29, 2008
February 1, 2008
5 years
February 20, 2008
February 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left Ventricular Ejection Fraction(LVEF)
1, 3, 6 months, 1, 4 years
Secondary Outcomes (6)
in-stent restenosis
1, 3, 6 months, 1, 4 years
cardiac shock
1, 3, 6 months, 1, 4 years
myocardial viability of the infarcted area
1, 3, 6 months, 1, 4 years
end-diastolic Volume/end-systolic Volume(EDV/ESV)
1, 3, 6 months, 1, 4 years
wall motion score index(WMSI)
1, 3, 6 months, 1, 4 years
- +1 more secondary outcomes
Study Arms (2)
1
PLACEBO COMPARATORPatients receive intracoronary injections of saline 7 days after PCI.
2
EXPERIMENTALPatients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Interventions
Patients receive intracoronary injections of saline 7 days after PCI.
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Department of Cardiology in Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haichang Wang, MD,PHD
Xijing Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 29, 2008
Study Start
March 1, 2003
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
February 29, 2008
Record last verified: 2008-02