Death, Left Ventricular Function Diastolic Dysfunction, Left Ventricular Function Systolic Dysfunction, Myocardial Reperfusion Injury
Conditions
Keywords
Bone Marrow Mononuclear cells;, Diabetes;, ST-segment Elevation Myocardial Infarction;, Percutaneous Coronary Intervention;, Left Ventricular Function
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.
Interventions
None listed
Sponsors
Xijing Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient death during the follow up period | 4years | Number of patient death during the follow up period as a measure of safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT) | 4 years | — |
| Infarct size as evaluated by Single-photon emission computed tomography (SPECT) | 4 years | — |
| Number of target vessel revascularization | 4 years | Number of target vessel revascularization during the follow up period |
| Left ventricular ejection fraction | 4 years | Left ventricular ejection fraction as evaluated by echocardiography and SPECT |
| Scores on the Seattle angina questionnaire | 4 years | — |
| six-min walk distance (6MWD) | 4 years | Quality of life as evaluated by 6-min walk distance |
| Angina class according to the canadian cardiovascular society (CCS) classification | 4 years | — |
Countries
China
Outcome results
None listed