Endocardial Stem Cells Approach Efficacy (ESCAPE)
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Location:
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Country:
Russia The primary objective of this study is to test whether endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival rates compared with MED alone.
Eligible Ages for Trial:
21-75
Eligible Genders for Trial:
Both
Illness:
Heart Disease Inclusion Criteria:
- Men and women who are not of childbearing potential
- Age 21-75 years.
- Patients with CAD, NYHA and CCS angina III-IV functional class
- LVEF less than 35% measured by echocardiography or SPECT within three months of study entry
- Unsuitable for initial or repeated conventional revascularization (CABG or PCI)
Exclusion Criteria:
- Failure to provide informed consent.
- Plan for PCI or CABG.
- Non-cardiac illness with a life expectancy of less than 3 year.
- Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
- Previous heart, kidney, liver, or lung transplantation.
- Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
- Recent acute myocardial infarction (AMI) within 90 days of study entry
- Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
- History of moderate to severe aortic stenosis or prosthetic aortic valve
- Permanent atrial fibrillation
- Thrombosis in LV, based on echocardiography data
February 1, 2007 - March 1, 2011
Trial Status:
Recruiting Contact:
Evgeniy A Pokushalov, Prof. +7 383 332 7655 E.Pokushalov@gmail.com
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