Skip to main content
OpenTrials
Completed

NCT Number: NCT00272571

The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells

The objectives of the study are to test the hypothesis that external counter pulsation therapy (ECPT) provides clinical benefit by improving the number and function of endothelial progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neufeld cardiac research institute, Sheba medical center

Tel Litwinsky, Israel

About this study

ECPT is a non-invasive approach for increasing blood flow to the heart in patients with myocardial ischemia. ECPT produces beneficial effects in coronary artery disease (CAD) patients. However, the exact mechanisms of ECPT action are not defined yet. Evidence has now accumulated that bone marrow-derived cells with angiogenic capability, termed EPCs, circulate in the blood of adults. EPCs possess the ability to home to sites of ischemia and contribute to neoangiogenesis.

We prospectively study CAD patients [Canadian Cardiovascular Society (CCS) angina class II-IV], before and after ECPT , and compare them with age- and sex-matched controls. Peripheral blood CD34+ cells, EPCs (CD34/VEGFR2+ cells), EPC colony forming units (CFUs) and brachial artery endothelial function is assessed prior to and after ECPT. Percent improvement in endothelium-dependent brachial artery flow-mediated dilatation (%FMD) is assessed using high-resolution ultrasound.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • coronary artery disease
  • CCS angina class II-IV

Exclusion criteria

  • aortic regurgitation
  • acute myocardial infarction <3 months
  • systemic hypertension >180/110 mm
  • atrial fibrillation
  • deep vein thrombosis
  • phlebitis and hemorrhagic diathesis
  • pregnancy
  • abdominal aortic aneurism
  • metastatic tumor

Treatment and study plan

External counter pulsation therapy

Procedure

Primary outcomes

  1. The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)

Secondary outcomes

  1. Brachial artery endothelial function (before and one week after treatment)

  2. CCS angina class (before and one week after treatment)

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris

Important dates

Study start
2004
Study completion
2006
First posted
Jan 6, 2006
Registry last updated
Jan 31, 2006

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.