Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration

Study Overview
=================
Brief Summary
-----------------
After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction, 60 patients were randomly assigned to either a control group (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4·8 days (SD 1·3) after PCI. Primary endpoint was global left-ventricular ejection fraction (LVEF) change from baseline to 6 months' follow-up, as determined by cardiac MRI. Image analyses were done by two investigators blinded for treatment assignment. Analysis was per protocol. Global LVEF at baseline (determined 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had increased by 0·7 percentage points in the control group and 6·7 percentage points in the bone-marrow-cell group (P=0·0026). Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk of adverse clinical events, in-stent restenosis, or proarrhythmic effects.

Detailed Description
-----------------
Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aimed to assess whether intracoronary transfer of autologous bone-marrow cells could improve global left-ventricular ejection fraction (LVEF) at 6 months' follow-up. After successful percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction, 60 patients were randomly assigned to either a control group (n=30) that received optimum postinfarction medical treatment, or a bone-marrow-cell group (n=30) that received optimum medical treatment and intracoronary transfer of autologous bone-marrow cells 4·8 days (SD 1·3) after PCI. Primary endpoint was global left-ventricular ejection fraction (LVEF) change from baseline to 6 months' follow-up, as determined by cardiac MRI. Image analyses were done by two investigators blinded for treatment assignment. Analysis was per protocol. Global LVEF at baseline (determined 3·5 days [SD 1·5] after PCI) was 51·3 (9·3%) in controls and 50·0 (10·0%) in the bone-marrow cell group (p=0·59). After 6 months, mean global LVEF had increased by 0·7 percentage points in the control group and 6·7 percentage points in the bone-marrow-cell group (P=0·0026). Transfer of bone-marrow cells enhanced left-ventricular systolic function primarily in myocardial segments adjacent to the infarcted area. Cell transfer did not increase the risk of adverse clinical events, in-stent restenosis, or proarrhythmic effects. Intracoronary transfer of autologous bone-marrow-cells promotes improvement of left-ventricular systolic function in patients after acute myocardial infarction.

Official Title
-----------------
Bone Marrow Transfer to Enhance ST-Elevation Infarct Regeneration-1

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Intracoronary bone marrow cell transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were eligible if they were admitted within 5 days of the onset of symptoms of a first ST-segment elevation myocardial infarction Had undergone successful PCI with stent implantation in the infarctrelated artery Had hypokinesia or akinesia involving more than two thirds of the left-ventricular anteroseptal, lateral, and/or inferior wall, as shown by angiography done immediately after PCI. Exclusion Criteria: We excluded patients who had multivessel coronary artery disease, pulmonary edema, cardiogenic shock, advanced renal or hepatic dysfunction, or documented terminal illness or cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intracoronary bone marrow cell transfer|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction change between groups at month 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Left ventricular volumes |  |  | 
| Infarct size |  |  | 
| Subgroup analyses |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Bone marrow cells, Intracoronary