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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01307371
First received: February 24, 2011
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Number of patient death during the follow up period [ Time Frame: 4years ] [ Designated as safety issue: Yes ]
    Number of patient death during the follow up period as a measure of safety


Secondary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Left ventricular ejection fraction as evaluated by echocardiography and SPECT

  • Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Infarct size as evaluated by Single-photon emission computed tomography (SPECT) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Number of target vessel revascularization [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Number of target vessel revascularization during the follow up period

  • Angina class according to the canadian cardiovascular society (CCS) classification [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Scores on the Seattle angina questionnaire [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • six-min walk distance (6MWD) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Quality of life as evaluated by 6-min walk distance


Biospecimen Retention:   Samples With DNA

Serum, Plasma


Estimated Enrollment: 110
Study Start Date: March 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes
Patients with diabetes.
non-diabetes
Patients without diabetes.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided

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
Study First Received: February 24, 2011
Last Updated: February 28, 2011
Health Authority: China: Food and Drug Administration

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
Myocardial Reperfusion Injury
Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cardiomyopathies
Postoperative Complications

ClinicalTrials.gov processed this record on May 16, 2013