Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI

Launched by AMERICAN HEART OF POLAND · Dec 18, 2014

Keywords

ClinConnect Summary

The study is divided into 3 parts:

* Screening phase: Patients will be recruited at the investigational clinical centers. Alternatively, patients who had primary PCI performed at institutions different from the investigational sites can also be enrolled. Interested patients may be referred for screening to any of the participating study sites after acute reperfusion therapy. Informed consent and assessment of eligibility of patients with respect to in- and exclusion criteria will be done at the investigational site. If all other eligibility criteria are met, echocardiography will be perfor...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women of any ethnic origin aged ≥ 18 years.
• • 2. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
• • 3. 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.
• • 4. 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
• • 5. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
• • 6. LVEF≤45% with significant regional wall motion abnormality assessed by computed tomography (CT) 30 days after reperfusion therapy with no LVEF improvement ≥5%.
• Exclusion Criteria:
• • 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 BM-MNC infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed)
• • 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 non-cardiac cause or neoplastic disease