Endocardial Stem Cells Approach Efficacy (ESCAPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT00841958
First received: February 10, 2009
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Myocardial Ischemia
Procedure: Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: February 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
    Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841958

Locations
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

Additional Information:
Publications:
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT00841958     History of Changes
Other Study ID Numbers: SCVM-029, RU002
Study First Received: February 10, 2009
Last Updated: April 23, 2012
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014