Coronary Artery DiseaseNCT00272571
The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells
A study testing External counter pulsation therapy in people with Coronary Artery Disease, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- External counter pulsation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2004to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease
- CCS angina class II-IV
Who cannot join
- aortic regurgitation
- acute myocardial infarction <3 months
- systemic hypertension >180/110 mm
- atrial fibrillation
- deep vein thrombosis
- phlebitis and hemorrhagic diathesis
Show all 9Show fewer
- pregnancy
- abdominal aortic aneurism
- metastatic tumor
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neufeld cardiac research institute, Sheba medical center
Tel HaShomer
About this study
Official title: The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- External counter pulsation therapy
- Keywords
- ECPT, endothelial progenitor cells
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External counter pulsation therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startAug 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Jonathan Leor, Prof., Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272571
- Sponsor's protocol ID
- SHEBA-02-2701-JL-CTIL
- Status last verified
- Jan 2006
- First submitted
- 4 Jan 2006
- Last updated
- 31 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris
- ClinicalTrials.gov ID
- NCT00272571
- Acronym / sponsor ID
- SHEBA-02-2701-JL-CTIL
- Conditions
- Coronary Artery Disease
- Keywords
- ECPT, endothelial progenitor cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2004
- Study completion
- Jan 2006
- First posted
- 6 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- coronary artery disease
- CCS angina class II-IV
Key exclusion criteria (9 listed)
- aortic regurgitation
- acute myocardial infarction <3 months
- systemic hypertension >180/110 mm
- atrial fibrillation
- deep vein thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External counter pulsation therapy | Procedure or surgery | – |
Primary outcome
The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)
2 secondary outcomes
Brachial artery endothelial function (before and one week after treatment)
CCS angina class (before and one week after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Leor, Prof. principal investigator
Chaim Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External counter pulsation therapy in people with Coronary Artery Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2006; AzTrials last refreshed its copy on 7 Nov 2026.