A randomised trial to see if injecting patients' own bone marrow derived stem cells through their coronary artery changes mortality rate in patients after suffering from a heart attack
- Conditions
- Myocardial Infarction with reduced Left Ventricular ejection fractionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001495-11-NL
- Lead Sponsor
- Queen Mary University London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3000
1. Signed and dated informed consent
2. Men and women of any ethnic origin aged = 18 years
3. Patients with acute STelevation (including new LBBB) myocardial infarction as defined by the universal definition of AMI.
4. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow =2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis
5. Left ventricular ejection fraction = 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy
6. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1200
1. Participation in another clinical trial within 30 days prior to randomisation
2. Previously received stem/progenitor cell therapy
3. Pregnant or nursing women
4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the
protocol
5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BMMNC infusion (additional revascularisations after primary PCI and before BMMNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be madfe at the time of the index procedure and explicitly stated at the time.
6. Cardiogenic shock requiring mechanical support
7. Platelet count <100,000/µl, or hemoglobin <8.5 g/dl
8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl
9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
10. Clinically significant bleeding within 3 months prior screening
11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
12. Life expectancy of less than 2 years from any noncardiac cause or neoplastic disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of the study is to assess if the administrator of a single injection of patient's own bone marrow derived stem cells into their coronary arteries will reduce all cause mortality.;Secondary Objective: Looking at the time from randomisation to cardiac and cardiovascular events including cardiac death.;Primary end point(s): Time from Randomisation to all-cause-death;Timepoint(s) of evaluation of this end point: The outcome will be assessed at 30 days and every 3 months until the end of the study or up to two years after randomisation with a minimum of 2 years follow up.
- Secondary Outcome Measures
Name Time Method