Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Coronary Heart Disease Clinical Trial

— EECPVHS  

Official title:

Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102502
• Other study ID #: EECP- 2
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 10, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Hemorrhagic disease

• Lower limb infection, phlebitis

• Deep venous thrombosis

• Malignant disease

• INR > 2.5

• Uncontrolled hypertension, defined as SBP > 180mmHg or DBP > 110mmHg

• Pregnancy

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• 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 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.

Drug:
• Medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs(aspirin or Clopidogrel ), anti-ischemic drugs (Nitroglycerin)

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat- sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. Epub 2007 Oct 1. Review. Erratum in: J Am Coll Cardiol. 2007 Dec 18;50(25):2441. — View Citation

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. Epub 2006 Aug 28. — View Citation

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. Epub 2007 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Change in atherosclerosis	Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity	At baseline and week 7 (post intervention)