Stable Chronic AnginaPhase 3ECP-CADNCT03075124
Effect of External Counter Pulsation on Coronary Artery Disease
A Phase 3 study testing External Counter Pulsation in people with Stable Chronic Angina and Coronary Artery Disease, run by Eighth Affiliated Hospital, Sun Yat-sen University at 4 sites in China.
Trial summary
Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens, external counter pulsation (ECP) has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, no multi-center control clinical study has been reported for further recommendation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable Chronic Angina, Coronary Artery Disease
- What is being tested?
- External Counter Pulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 4 sitesChina
- Study dates
- 8 Jun 2018to 30 Jun 2019
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of coronary artery disease;
- Signed informed consent.
Who cannot join
- Obvious aortic insufficiency;
- Aortic aneurysm;
- Aortic dissection;
- Coronary fistula or severe coronary aneurysm;
- Symptomatic Congestive heart failure;
- Valvular heart disease;
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- Congenital heart diseases;
- Cardiomyopathies
- Cerebral hemorrhage within six months;
- Uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg;
- Lower limb infection;
- Deep venous thrombosis;
- Progressive malignancies
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Tianlun Yang, MD, +8613707315500
- Recruiting
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality
Weiming Li, MD, +86 18917683469
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University,
Xi’an, Shanxi
Yongqin Li, MD, +86 13572107879
Xi Li, MD
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Hui Zhang, MD, +86 13298322770
About this study
Official title: Effect of External Counter Pulsation on Coronary Artery Disease (ECP-CAD)
Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens, external counter pulsation (ECP) has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, no multi-center control clinical study has been reported for further recommendation. The aim of this study is to evaluate the effect of ECP on CAD. To address this assumption, investigators enroll participants with stable CAD and randomize them into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks, and the follow-up will last for 1 year. The primary endpoint is the 1-year composite cardiovascular events (CCE), secondary endpoints include frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function.
Read the detailed description
CAD is the leading cause of non-tumor mortality in most countries, ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole. Cumulative evidences demonstrate that ECP can improve life quality and release refractory angina which is not optimally controlled despite optimal medical management and coronary revascularization in patients with CAD, though the previous multi-center control trial (PROBE-EECP) had been designed, no result about the effect of ECP on the prognosis of CAD has been reported. Thus, this study is designed to enroll 380 participants with stable CAD after evaluation of frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function, participants will be randomized into ECP intervention group or control group. All participants receive Guideline-driven standard medical treatment, ECP will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. Up to the end of ECP intervention, CCE will be follow up to 1 year, meanwhile, items as above will be retested for comparison.
- Conditions
- Stable Chronic Angina, Coronary Artery Disease
- Being tested
- External Counter Pulsation
- Keywords
- Coronary Artery Disease, external counter pulsation, major adverse cardiovascular events
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Counter PulsationDevice
A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
| Study group | Role | What they receive |
|---|---|---|
| External Counter Pulsation group | Experimental | A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. Receives: Device: External Counter Pulsation |
| Control group | No intervention | Guideline-driven standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite cardiovascular events (CCE)
Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction；rehospitalization rate
Measured: Change from Baseline at 1-year
Secondary outcomes (3)
Frequency of angina pectoris per week
Frequency of angina pectoris
Measured: Change from Baseline frequency at 1 year
Dosage of Nitroglycerin use per week
total dosage of nitroglycerin
Measured: Change from Baseline frequency and dosage at 1 year
6-minute walking distance
6-minute walking distance
Measured: Change from Baseline distance at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start8 Jun 2018 (estimated)
- Primary completion28 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Chronic AnginaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital of Zhengzhou University, Shanghai 10th People's Hospital, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Guifu Wu, Eighth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075124
- Sponsor's protocol ID
- SYSU8001
- Acronym
- ECP-CAD
- Status last verified
- Dec 2017
- First submitted
- 28 Feb 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of External Counter Pulsation on Coronary Artery Disease (ECP-CAD)
- ClinicalTrials.gov ID
- NCT03075124
- Acronym / sponsor ID
- ECP-CAD / SYSU8001
- Conditions
- Stable Chronic Angina, Coronary Artery Disease
- Keywords
- Coronary Artery Disease, external counter pulsation, major adverse cardiovascular events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital of Zhengzhou University, Shanghai 10th People's Hospital, Xiangya Hospital of Central South University
- Study start
- 8 Jun 2018 (estimated)
- Primary completion
- 28 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 9 Mar 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.
Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens, external counter pulsation (ECP) has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, no multi-center control clinical study has been reported for further recommendation. The aim of this study is to evaluate the effect of ECP on CAD. To address this assumption, investigators enroll participants with stable CAD and randomize them into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks, and the follow-up will last for 1 year. The primary endpoint is the 1-year composite cardiovascular events (CCE), secondary endpoints include frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function.
Detailed description
CAD is the leading cause of non-tumor mortality in most countries, ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole. Cumulative evidences demonstrate that ECP can improve life quality and release refractory angina which is not optimally controlled despite optimal medical management and coronary revascularization in patients with CAD, though the previous multi-center control trial (PROBE-EECP) had been designed, no result about the effect of ECP on the prognosis of CAD has been reported. Thus, this study is designed to enroll 380 participants with stable CAD after evaluation of frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function, participants will be randomized into ECP intervention group or control group. All participants receive Guideline-driven standard medical treatment, ECP will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. Up to the end of ECP intervention, CCE will be follow up to 1 year, meanwhile, items as above will be retested for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Counter Pulsation group | Experimental | Device: External Counter PulsationA standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. |
| Control group | No intervention | –Guideline-driven standard medical treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of coronary artery disease;
- Signed informed consent.
Key exclusion criteria (13 listed)
- Obvious aortic insufficiency;
- Aortic aneurysm;
- Aortic dissection;
- Coronary fistula or severe coronary aneurysm;
- Symptomatic Congestive heart failure;
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 PulsationA standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. | Device | External Counter Pulsation group |
Primary outcome
composite cardiovascular events (CCE)
Time frame: Change from Baseline at 1-year
Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction；rehospitalization rate
3 secondary outcomes
Frequency of angina pectoris per week
Time frame: Change from Baseline frequency at 1 year
Dosage of Nitroglycerin use per week
Time frame: Change from Baseline frequency and dosage at 1 year
6-minute walking distance
Time frame: Change from Baseline distance at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing External Counter Pulsation in people with Stable Chronic Angina and Coronary Artery Disease, run by Eighth Affiliated Hospital, Sun Yat-sen University at 4 sites 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 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guifu Wu, PhD (+8615989893111, wuguifu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite cardiovascular events (CCE) (time frame: Change from Baseline at 1-year). 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 13 Dec 2017.