Endocardial Stem Cells Approach Efficacy (ESCAPE)
April 23, 2012 updated by: Meshalkin Research Institute of Pathology of Circulation
Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients
The primary objective of this study is to test that 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 compared to MED alone
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Novosibirsk, Russian Federation, 630055
- State Research Institute of Circulation Pathology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1
Time Frame: 2007-2010
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2007-2010
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
February 10, 2009
First Submitted That Met QC Criteria
February 11, 2009
First Posted (Estimate)
February 12, 2009
Study Record Updates
Last Update Posted (Estimate)
April 24, 2012
Last Update Submitted That Met QC Criteria
April 23, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCVM-029
- RU002 (Other Identifier: State Research Institute of Circulation Pathology)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.