NCT00272571

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2004

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
Last Updated

January 31, 2006

Status Verified

January 1, 2006

First QC Date

January 4, 2006

Last Update Submit

January 29, 2006

Conditions

Coronary Artery Disease

Keywords

ECPT, endothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

  • CCS angina class (before and one week after treatment)

Interventions

External counter pulsation therapyPROCEDURE

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary artery disease
  • CCS angina class II-IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neufeld cardiac research institute, Sheba medical center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jonathan Leor, Prof.

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 6, 2006

Study Start

August 1, 2004

Study Completion

January 1, 2006

Last Updated

January 31, 2006

Record last verified: 2006-01

Locations

IL(1)