Coronary Heart DiseaseEECPVHSNCT03102502
Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
A study testing EECP and Medical therapy in people with Coronary Heart Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- EECP and Medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2017to 10 Jan 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 20 to 80 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
- Arrythmias 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
- INR > 2.5
- Uncontrolled hypertension, defined as SBP > 180mmHg or DBP > 110mmHg
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat- sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms
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. Hemodynamic parameters, vascular status and function will be measured.
- Conditions
- Coronary Heart Disease
- Being tested
- EECP, Medical therapy
- Keywords
- Coronary Heart Disease, Atherosclerosis, Vascular Endothelium, Counterpulsation, External
- Medical subject headings
- Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EECPDevice
Also called Enhanced External Counterpulsation
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 is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.
Medical therapyDrug
Also called Guideline- driven medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
| Study group | Role | What they receive |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period. Receives: Device: EECP; Drug: Medical therapy |
| Control | Active comparator | Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention. Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood flow velocity
Change from baseline in blood flow velocity measured by color Doppler ultrasound system
Measured: At baseline, during EECP and week 7 (post intervention)
Secondary outcomes (2)
Change in vascular endothelial function
Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system
Measured: At baseline and week 7 (post intervention)
Change in atherosclerosis
Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity
Measured: At baseline and week 7 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start10 Mar 2017
- Primary completion10 Oct 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Model description
- Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhang, Sun Yat-sen University
- Investigators
- Yan Zhang, M. D., Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityZhensheng Zheng, M. D., Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102502
- Sponsor's protocol ID
- EECP- 2
- Acronym
- EECPVHS
- Status last verified
- Oct 2020
- First submitted
- 31 Mar 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
Publications
Manchanda A, Soran O. Enhanced external counterpulsation and future directions: step beyond medical management for patients with angina and heart failure. J Am Coll Cardiol. 2007 Oct 16;50(16):1523-31. doi: 10.1016/j.jacc.2007.07.024. Epub 2007 Oct 1.
PubMed 17936150Nichols WW, Estrada JC, Braith RW, Owens K, Conti CR. Enhanced external counterpulsation treatment improves arterial wall properties and wave reflection characteristics in patients with refractory angina. J Am Coll Cardiol. 2006 Sep 19;48(6):1208-14. doi: 10.1016/j.jacc.2006.04.094. Epub 2006 Aug 28.
PubMed 16979007Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
PubMed 20921442Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.
PubMed 17620513
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
- Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
- ClinicalTrials.gov ID
- NCT03102502
- Acronym / sponsor ID
- EECPVHS / EECP- 2
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, Atherosclerosis, Vascular Endothelium, Counterpulsation, External
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 5 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 present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms
Detailed description
Patients with coronary heart disease will be randomized into two groups: standard medical treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters, vascular status and function will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Device: EECP, Drug: Medical therapyPatients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period. |
| Control | Active comparator | Drug: Medical therapyPatients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention. |
Who may qualify
- Ages
- 20 to 80 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
- Arrythmias 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 |
|---|---|---|
| EECPAlso: Enhanced External CounterpulsationEnhanced 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 is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner. | Device | Enhanced External Counterpulsation |
| Medical therapyAlso: Guideline- driven medical therapyGuideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin） | Drug | Control, Enhanced External Counterpulsation |
Primary outcome
Change in blood flow velocity
Time frame: At baseline, during EECP and week 7 (post intervention)
Change from baseline in blood flow velocity measured by color Doppler ultrasound system
2 secondary outcomes
Change in vascular endothelial function
Time frame: At baseline and week 7 (post intervention)
Change in atherosclerosis
Time frame: At baseline and week 7 (post intervention)
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.
- Background: PubMed 17936150Manchanda A, Soran O. Enhanced external counterpulsation and future directions: step beyond medical management for patients with angina and heart failure. J Am Coll Cardiol. 2007 Oct 16;50(16):1523-31. doi: 10.1016/j.jacc.2007.07.024. Epub 2007 Oct 1.
- Background: PubMed 16979007Nichols WW, Estrada JC, Braith RW, Owens K, Conti CR. Enhanced external counterpulsation treatment improves arterial wall properties and wave reflection characteristics in patients with refractory angina. J Am Coll Cardiol. 2006 Sep 19;48(6):1208-14. doi: 10.1016/j.jacc.2006.04.094. Epub 2006 Aug 28.
- Background: PubMed 20921442Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
- Background: PubMed 17620513Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.
- Individual participant dataSharing planned: No
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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 EECP and 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 blood flow velocity (time frame: At baseline, during EECP and week 7 (post intervention)). 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 NCT03102502, which also lists 4 linked publications.
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.