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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | Active Comparator | Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EECP | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood flow velocity | Change from baseline in blood flow velocity measured by color Doppler ultrasound system | At baseline, during EECP and week 7 (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vascular endothelial function | Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system | At baseline and week 7 (post intervention) |
| Change in atherosclerosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Zhang, M. D. | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Zhensheng Zheng, M. D. | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat- sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17936150 | Background | 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. | |
| 16979007 | Background | Nichols 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. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
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| Medical therapy | Drug | Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin） |
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Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity
| At baseline and week 7 (post intervention) |
| 20921442 | Background | Braith 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. |
| 17620513 | Background | Zhang 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |