Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

NCT03102502 | Completed DMC

• 1 other identifier: EECP- 2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Heart Disease

Keywords

Coronary Heart Disease; Atherosclerosis; Vascular Endothelium; Counterpulsation, External

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in vascular endothelial function

  At baseline and week 7 (post intervention)

• Change in atherosclerosis

  At baseline and week 7 (post intervention)

Study Arms (2)

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.

Device: EECP; Drug: Medical therapy

Control

ACTIVE COMPARATOR

Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.

Drug: Medical therapy

Interventions

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.

Also known as: Enhanced External Counterpulsation

Enhanced External Counterpulsation

Medical therapy DRUG

Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）

Also known as: Guideline- driven medical therapy

Control; Enhanced External Counterpulsation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat- sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (4)

• 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.

  PMID: 17936150 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.

  PMID: 16979007 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.

  PMID: 20921442 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.

  PMID: 17620513 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Atherosclerosis

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 5, 2017
• Study Start: March 10, 2017
• Primary Completion: October 10, 2018
• Study Completion: January 10, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)