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Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)

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ClinicalTrials.gov Identifier: NCT01307371
Recruitment Status : Unknown
Verified February 2011 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
Xijing Hospital

Brief Summary:
The purpose of this study is to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary intervention (PCI).

Condition or disease Phase
Left Ventricular Function Systolic Dysfunction Left Ventricular Function Diastolic Dysfunction Death Myocardial Reperfusion Injury Phase 1

Detailed Description:
Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone PCI.

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)
Study Start Date : March 2007
Primary Completion Date : March 2008
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Group/Cohort
Diabetes
Patients with diabetes.
non-diabetes
Patients without diabetes.



Primary Outcome Measures :
  1. Number of patient death during the follow up period [ Time Frame: 4years ]
    Number of patient death during the follow up period as a measure of safety


Secondary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 4 years ]
    Left ventricular ejection fraction as evaluated by echocardiography and SPECT

  2. Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT) [ Time Frame: 4 years ]
  3. Infarct size as evaluated by Single-photon emission computed tomography (SPECT) [ Time Frame: 4 years ]
  4. Number of target vessel revascularization [ Time Frame: 4 years ]
    Number of target vessel revascularization during the follow up period

  5. Angina class according to the canadian cardiovascular society (CCS) classification [ Time Frame: 4 years ]
  6. Scores on the Seattle angina questionnaire [ Time Frame: 4 years ]
  7. six-min walk distance (6MWD) [ Time Frame: 4 years ]
    Quality of life as evaluated by 6-min walk distance


Biospecimen Retention:   Samples With DNA
Serum, Plasma


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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of STEMI with the culprit lesion of left anterior decending (LAD)coronary artery were enrolled in this study.
Criteria

Inclusion Criteria:

  • age between 25 and 60 years old
  • STEMI according to the WHO definition
  • PCI <12 hours from the onset of symptoms
  • LAD disease with an open infarct related artery

Exclusion Criteria:

  • previous myocardial infarction (MI)
  • cardiomyopathy
  • atrial fibrillation or flutter
  • previous heart surgery
  • severe valvular heart disease
  • disease of the hematopoietic system
  • NYHA functional class IV heart failure at baseline
  • severe renal, lung and liver disease
  • cancer
  • intra-cardiac thrombus
  • bone marrow disease

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): NCT01307371


Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Dongdong Sun, MD, PhD    86 29 84775183    wintersun3@gmail.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Feng Cao, MD, PhD Fourth Military Medical University

Responsible Party: Department of Cardiovascular medicine, Xijing Hospital, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01307371     History of Changes
Other Study ID Numbers: DIABETES-STEMI
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: February 2011

Keywords provided by Xijing Hospital:
Bone Marrow Mononuclear cells;
Diabetes;
ST-segment Elevation Myocardial Infarction;
Percutaneous Coronary Intervention;
Left Ventricular Function

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
ST Elevation Myocardial Infarction
Myocardial Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Cardiomyopathies