Coronary Artery DiseasePROBE-EECPNCT01198405
Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease
A study testing Enhanced external counterpulsation and Guideline-driven standard medical therapy in people with Coronary Artery Disease, run by Sun Yat-sen University at 4 sites in China.
Trial summary
To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Enhanced external counterpulsation and Guideline-driven standard medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2008to Sep 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least one coronary lesion of more than 50% stenosis shown by angiography
- history of acute myocardial infarction(at least one month before)
- history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting)
- typical angina episodes with evidence of myocardial ischemia
- 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, congenital heart diseases, cardiomyopathies
- Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency;
- Lower limb infection, phlebitis, varicosity, deep venous thrombosis;
- Progressive malignancies or diseases with poor prognosis;
- uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The 1st Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Gui-fu Wu, M.D. & Ph.D., +86-135-7001-0112, eecpchina@yahoo.com.cn
Da-ya Yang, M.D., +86-135-7056-7490, y2kchocolate@163.com
- Recruiting
The 2nd Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jing-feng Wang, M.D., +86-136-0289-0860
Ru-qiong Nie, M.D., +86-136-0047-9016
- Recruiting
The 3rd Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Lin Chen, M.D., +86-138-0251-8615
Xiao-xian Qian, M.D., +86-137-1926-1500
- Recruiting
The 5th Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Jian Peng, M.D., +86-136-0036-1608
About this study
Official title: A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease
To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Enhanced external counterpulsation, Guideline-driven standard medical therapy
- Keywords
- coronary artery disease, enhanced external counterpulsation
- 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.
Enhanced external counterpulsationDevice
Treatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year.
Guideline-driven standard medical therapyDrug
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
| Study group | Role | What they receive |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy. Receives: Device: Enhanced external counterpulsation |
| Control | Active comparator | Guideline-driven standard medical therapy. Receives: Drug: Guideline-driven standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
Measured: up to 5 years
Secondary outcomes (9)
vascular endothelial function
measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
Measured: up to 5 years
cardiac structure and exercise tolerance
cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test
Measured: up to 5 years
new-onset diabetes
fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
Measured: up to 5 years
atherosclerosis
peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP \& DBP)
Measured: up to 5 years
24-hour urinary protein
24-hour urinary protein/albumin by urinalysis
Measured: up to 5 years
all-cause mortality
Measured: up to 5 years
revascularization rate
Measured: up to 5 years
rehospitalization rate
Measured: up to 5 years
rate of acute myocardial infarction
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Investigator
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Zhi-min Du, M.D., Principal investigator, The 1st Affiliated Hospital of Sun Yat-sen UniversityGui-fu Wu, M.D. & Ph.D., Study director, The 1st Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198405
- Sponsor's protocol ID
- SYSU-5010-2008
- Acronym
- PROBE-EECP
- Status last verified
- Jan 2008
- First submitted
- 29 Jul 2010
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
PubMed 18404725Kitsou V, Xanthos T, Roberts R, Karlis GM, Padadimitriou L. Enhanced external counterpulsation: mechanisms of action and clinical applications. Acta Cardiol. 2010 Apr;65(2):239-47. doi: 10.2143/AC.65.2.2047060.
PubMed 20458834Manchanda 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 17936150Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G, Ochoa A, Kelsey SF, Kennard ED. Primer: practical approach to the selection of patients for and application of EECP. Nat Clin Pract Cardiovasc Med. 2006 Nov;3(11):623-32. doi: 10.1038/ncpcardio0691.
PubMed 17063167Cohn PF. Enhanced external counterpulsation for the treatment of angina pectoris. Prog Cardiovasc Dis. 2006 Sep-Oct;49(2):88-97. doi: 10.1016/j.pcad.2006.04.001.
PubMed 17046434O'Rourke MF, Hashimoto J. Enhanced external counterpulsation why the benefit? J Am Coll Cardiol. 2006 Sep 19;48(6):1215-6. doi: 10.1016/j.jacc.2006.06.036. Epub 2006 Aug 28. No abstract available.
PubMed 16979008Michaels AD, Raisinghani A, Soran O, de Lame PA, Lemaire ML, Kligfield P, Watson DD, Conti CR, Beller G. The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J. 2005 Nov;150(5):1066-73. doi: 10.1016/j.ahj.2005.01.054.
PubMed 16291000Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto R, Ferrans CE, Keller S. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. 2002 Jan;50(1):25-32. doi: 10.2310/6650.2002.33514.
PubMed 11813825Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.
PubMed 10362181
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT01198405
- Acronym / sponsor ID
- PROBE-EECP / SYSU-5010-2008
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, enhanced external counterpulsation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 10 Sep 2010 (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.
To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Device: Enhanced external counterpulsationTreatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy. |
| Control | Active comparator | Drug: Guideline-driven standard medical therapyGuideline-driven standard medical therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least one coronary lesion of more than 50% stenosis shown by angiography
- history of acute myocardial infarction(at least one month before)
- history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting)
- typical angina episodes with evidence of myocardial ischemia
- Signed informed consent
Key exclusion criteria (8 listed)
- Obvious aortic insufficiency, aortic aneurysm, aortic dissection
- Coronary fistula or severe coronary aneurysm
- Symptomatic Congestive heart failure
- Valvular heart disease, congenital heart diseases, cardiomyopathies
- Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency;
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 |
|---|---|---|
| Enhanced external counterpulsationTreatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year. | Device | Enhanced External Counterpulsation |
| Guideline-driven standard medical therapyStandard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians | Drug | Control |
Primary outcome
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
Time frame: up to 5 years
9 secondary outcomes
vascular endothelial function
Time frame: up to 5 years
cardiac structure and exercise tolerance
Time frame: up to 5 years
new-onset diabetes
Time frame: up to 5 years
atherosclerosis
Time frame: up to 5 years
24-hour urinary protein
Time frame: up to 5 years
all-cause mortality
Time frame: up to 5 years
revascularization rate
Time frame: up to 5 years
rehospitalization rate
Time frame: up to 5 years
rate of acute myocardial infarction
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2010.
- Background: PubMed 18404725Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
- Background: PubMed 20458834Kitsou V, Xanthos T, Roberts R, Karlis GM, Padadimitriou L. Enhanced external counterpulsation: mechanisms of action and clinical applications. Acta Cardiol. 2010 Apr;65(2):239-47. doi: 10.2143/AC.65.2.2047060.
- 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 17063167Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G, Ochoa A, Kelsey SF, Kennard ED. Primer: practical approach to the selection of patients for and application of EECP. Nat Clin Pract Cardiovasc Med. 2006 Nov;3(11):623-32. doi: 10.1038/ncpcardio0691.
- Background: PubMed 17046434Cohn PF. Enhanced external counterpulsation for the treatment of angina pectoris. Prog Cardiovasc Dis. 2006 Sep-Oct;49(2):88-97. doi: 10.1016/j.pcad.2006.04.001.
- Background: PubMed 16979008O'Rourke MF, Hashimoto J. Enhanced external counterpulsation why the benefit? J Am Coll Cardiol. 2006 Sep 19;48(6):1215-6. doi: 10.1016/j.jacc.2006.06.036. Epub 2006 Aug 28. No abstract available.
- Background: PubMed 16291000Michaels AD, Raisinghani A, Soran O, de Lame PA, Lemaire ML, Kligfield P, Watson DD, Conti CR, Beller G. The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J. 2005 Nov;150(5):1066-73. doi: 10.1016/j.ahj.2005.01.054.
- Background: PubMed 11813825Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto R, Ferrans CE, Keller S. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. 2002 Jan;50(1):25-32. doi: 10.2310/6650.2002.33514.
- Background: PubMed 10362181Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.
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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.
Zhi-min Du, M.D. principal investigator
The 1st Affiliated Hospital of Sun Yat-sen University
Gui-fu Wu, M.D. & Ph.D. study director
The 1st Affiliated Hospital of Sun Yat-sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced external counterpulsation and Guideline-driven standard medical therapy in people with Coronary Artery Disease, run by 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 5 inclusion and 8 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 10 Sep 2010. 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.
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 Yan Zhang, M.D. (+86-137-1123-4160, zhangyan1233456@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction (time frame: up to 5 years). 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 NCT01198405, which also lists 9 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 10 Sep 2010.