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OpenTrials
Completed

NCT Number: NCT00841958

Endocardial Stem Cells Approach Efficacy

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

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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous bone marrow mononuclear stem cells or peripheral blood stem cells

Procedure

Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Acronym: ESCAPE

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 12, 2009
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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