Coronary Heart DiseaseEECPVFNCT03106116

Efficacy of Enhanced External Counterpulsation on Ventricular Function

A study testing Experimental: Enhanced External Counterpulsation and Standard medical therapy in people with Coronary Heart Disease, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: Experimental: Enhanced External Counterpulsation and Standard medical therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: 15 Mar 2017to 30 Mar 2019
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 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
Or history of myocardial infarction
Or history of prior revascularization
Signed informed consent to participate in the study

Who cannot join

Clinically significant valvular heart disease
Aortic aneurysm
Congenital heart disease
Acute myocarditis
Arrhythmias significantly interfere with the triggering of the EECP device
History of cerebral hemorrhage

Show all 13Show fewer

Hemorrhagic disease
Lower limb infection, phlebitis
Deep venous thrombosis
Malignant disease
International normalized ratio (INR) > 2.5
Uncontrolled hypertension, defined as systolic blood pressure > 180mmHg or diastolic blood pressure > 110mmHg
Pregnancy

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital, Sun Yat- sen University
Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease

The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease

Read the detailed description

Patients with coronary heart disease will be randomized into two groups:

standard medical treatment and standard medical treatment plus EECP intervention. Ventricular structure and function will be measured and compared.

Conditions: Coronary Heart Disease
Being tested: Experimental: Enhanced External Counterpulsation, Standard medical therapy
Keywords: Coronary Heart Disease, Ventricular Function, Vascular Endothelium, Counterpulsation, External
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental: Enhanced External CounterpulsationDevice
Also called EECP
Enhanced External Counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day.
Standard medical therapyDrug
Also called Guideline- driven standard medical therapy
Guideline- driven standard medical treatment for 7 weeks

Study groups in NCT03106116
Study group	Role	What they receive
Enhanced External Counterpulsation	Experimental	Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease Receives: Device: Experimental: Enhanced External Counterpulsation; Drug: Standard medical therapy
Control	Active comparator	Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention Receives: Drug: Standard medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in heart function
Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks
Measured: 7 weeks

Secondary outcomes (2)

Change in cardiac chamber diameter
Change from baseline in cardiac chamber diameterat 7 weeks
Measured: 7 weeks
Change in ventricular wall thickness
Change from baseline in ventricular wall thickness
Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201730 Mar 2019

First posted10 Apr 2017
Study start15 Mar 2017
Primary completion30 Dec 2018
Study completion30 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03106116
Sponsor's protocol ID: EECP-3
Acronym: EECPVF
Status last verified: Oct 2020
First submitted: 4 Apr 2017
Last updated: 2 Nov 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease
ClinicalTrials.gov ID: NCT03106116
Acronym / sponsor ID: EECPVF / EECP-3
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease, Ventricular Function, Vascular Endothelium, Counterpulsation, External
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 15 Mar 2017 (actual)
Primary completion: 30 Dec 2018 (actual)
Study completion: 30 Mar 2019 (actual)
First posted: 10 Apr 2017 (actual)
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 purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease

Detailed description

Patients with coronary heart disease will be randomized into two groups:

standard medical treatment and standard medical treatment plus EECP intervention. Ventricular structure and function will be measured and compared.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Enhanced External Counterpulsation	Experimental	Device: Experimental: Enhanced External Counterpulsation, Drug: Standard medical therapyExperimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease
Control	Active comparator	Drug: Standard medical therapyGuideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
Or history of myocardial infarction
Or history of prior revascularization
Signed informed consent to participate in the study

Key exclusion criteria (13 listed)

Clinically significant valvular heart disease
Aortic aneurysm
Congenital heart disease
Acute myocarditis
Arrhythmias significantly interfere with the triggering of the EECP device

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
Experimental: Enhanced External CounterpulsationAlso: EECPEnhanced External Counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day.	Device	Enhanced External Counterpulsation
Standard medical therapyAlso: Guideline- driven standard medical therapyGuideline- driven standard medical treatment for 7 weeks	Drug	Control, Enhanced External Counterpulsation

Primary outcome

Change in heart function
Time frame: 7 weeks
Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks

2 secondary outcomes

Change in cardiac chamber diameter
Time frame: 7 weeks
Change in ventricular wall thickness
Time frame: 7 weeks

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 2 Nov 2020.
Individual participant dataSharing planned: No

Related trials for Coronary Heart Disease

Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
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RecruitingObservational study
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Not yet recruitingPhase 4
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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.

Yan Zhang, M. D. principal investigator

First Affiliated Hospital, Sun Yat-Sen University

Zhensheng Zheng, M. D. study director

First Affiliated Hospital, Sun Yat-Sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Enhanced External Counterpulsation and Standard medical therapy in people with Coronary Heart Disease, run by Sun Yat-sen University at 1 site in China.

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 4 inclusion and 13 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 2 Nov 2020. 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 China. 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?

Change in heart function (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03106116.

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 2 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.