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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00841958 |
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Date of registration:
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10/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Endocardial Stem Cells Approach Efficacy
ESCAPE |
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Scientific title:
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Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00841958 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Evgeny A Pokushalov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Research Institute of Circulation Pathology |
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Key inclusion & exclusion criteria
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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 (?ABG 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
Age minimum:
21 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Ischemia
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Intervention(s)
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Procedure: Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
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Primary Outcome(s)
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Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: ? = 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: ? > 1
[Time Frame: 2007-2010]
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Secondary ID(s)
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RU002
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SCVM-029
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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