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Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Xijing Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626145
First Posted: February 29, 2008
Last Update Posted: February 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Xijing Hospital
  Purpose
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.

Condition Intervention Phase
Myocardial Infarction Procedure: saline infusion Procedure: autologous bone marrow mononuclear cells infusion Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Left Ventricular Ejection Fraction(LVEF) [ Time Frame: 1, 3, 6 months, 1, 4 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: March 2003
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Patients receive intracoronary injections of saline 7 days after PCI.
Procedure: saline infusion
Patients receive intracoronary injections of saline 7 days after PCI.
Other Names:
  • saline placebo
  • placebo control
Experimental: 2
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Procedure: autologous bone marrow mononuclear cells infusion
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
Other Names:
  • autologous BMMC infusion
  • autologous bone marrow mononuclear cells transplantation
  • autologous BMMC intracoronary injection

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

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626145


Locations
China, Shaanxi
Department of Cardiology in Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Haichang Wang, MD,PHD Xijing Hospital
  More Information

Responsible Party: Haichang Wang / Director of Department of Cardiology of Xijing Hospital, Xijing Hospital of Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT00626145     History of Changes
Other Study ID Numbers: 00200301
First Submitted: February 20, 2008
First Posted: February 29, 2008
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Xijing Hospital:
BMMNC
STEMI
stem cell
intracoronary delivery

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases