Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Medical therapy; Device: EECP

• Registration Number: NCT03102502
• Lead Sponsor: Sun Yat-sen University

Brief 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

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 Timeline

• Study Start: 2017-03-10
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-05
• Primary Completion: 2018-10-10
• Study Completion: 2019-01-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Medical therapy	Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.
Enhanced External Counterpulsation	EECP	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.
Enhanced External Counterpulsation	Medical therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in blood flow velocity	At baseline, during EECP and week 7 (post intervention)	Change from baseline in blood flow velocity measured by color Doppler ultrasound system

Secondary Outcome Measures

Name	Time	Method
Change in vascular endothelial function	At baseline and week 7 (post intervention)	Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system
Change in atherosclerosis	At baseline and week 7 (post intervention)	Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat- sen University; 🇨🇳 Guangzhou, Guangdong, China