Clinical trial NCT01307371: Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Function Systolic Dysfunction
Left Ventricular Function Diastolic Dysfunction
Death
Myocardial Reperfusion Injury
Keywords: Bone Marrow Mononuclear cells;
Diabetes;
ST-segment Elevation Myocardial Infarction;
Percutaneous Coronary Intervention;
Left Ventricular Function
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 110
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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 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

Primary outcomes:
measure: Number of patient death during the follow up period
timeFrame: 4years
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 4 years
measure: Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
timeFrame: 4 years
measure: Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
timeFrame: 4 years
measure: Number of target vessel revascularization
timeFrame: 4 years
measure: Angina class according to the canadian cardiovascular society (CCS) classification
timeFrame: 4 years
measure: Scores on the Seattle angina questionnaire
timeFrame: 4 years
measure: six-min walk distance (6MWD)
timeFrame: 4 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Feng Cao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: