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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2009

Last Updated Date

April 23, 2012

Start Date ^ICMJE

February 2007

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841958 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endocardial Stem Cells Approach Efficacy

Official Title ^ICMJE

Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Ischemia

Intervention ^ICMJE

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%

Study Arm (s)

Not Provided

Publications *

Pokushalov E, Romanov A, Chernyavsky A, Larionov P, Terekhov I, Artyomenko S, Poveshenko O, Kliver E, Shirokova N, Karaskov A, Dib N. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. J Cardiovasc Transl Res. 2010 Apr;3(2):160-8. Epub 2009 Sep 24.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

250

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT00841958

Other Study ID Numbers ^ICMJE

SCVM-029, RU002

Has Data Monitoring Committee

Yes

Responsible Party

Meshalkin Research Institute of Pathology of Circulation

Study Sponsor ^ICMJE

Meshalkin Research Institute of Pathology of Circulation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Evgeny A Pokushalov, MD, PhD

State Research Institute of Circulation Pathology

Information Provided By

Meshalkin Research Institute of Pathology of Circulation

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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