Effect of External Counter Pulsation on Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— ECP-CAD  

Official title:

Effect of External Counter Pulsation on Coronary Artery Disease (ECP-CAD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075124
• Other study ID #: SYSU8001
• Status: Recruiting
• Phase: Phase 3
• First received: February 28, 2017
• Last updated: December 12, 2017
• Start date: June 8, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2017
• Source: Eighth Affiliated Hospital, Sun Yat-sen University
• Contact: Guifu Wu, PhD
• Phone: +8615989893111
• Email: wuguifu[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens, external counter pulsation (ECP) has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, no multi-center control clinical study has been reported for further recommendation. The aim of this study is to evaluate the effect of ECP on CAD. To address this assumption, investigators enroll participants with stable CAD and randomize them into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks, and the follow-up will last for 1 year. The primary endpoint is the 1-year composite cardiovascular events (CCE), secondary endpoints include frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function.

Description:

CAD is the leading cause of non-tumor mortality in most countries, ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole. Cumulative evidences demonstrate that ECP can improve life quality and release refractory angina which is not optimally controlled despite optimal medical management and coronary revascularization in patients with CAD, though the previous multi-center control trial (PROBE-EECP) had been designed, no result about the effect of ECP on the prognosis of CAD has been reported. Thus, this study is designed to enroll 380 participants with stable CAD after evaluation of frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function, participants will be randomized into ECP intervention group or control group. All participants receive Guideline-driven standard medical treatment, ECP will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. Up to the end of ECP intervention, CCE will be follow up to 1 year, meanwhile, items as above will be retested for comparison.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: June 30, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of coronary artery disease;

• Signed informed consent.

Exclusion Criteria:

• 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;

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

• Lower limb infection;

• Deep venous thrombosis;

• Progressive malignancies

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Chronic Angina

Intervention

Device:
• External Counter Pulsation
A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Tenth People's Hospital of Tongji University	Shang Hai	Shanghai
China	The Second Affiliated Hospital of Xi'an Jiaotong University,	Xi'an	Shanxi
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (5)

Lead Sponsor	Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University	Second Affiliated Hospital of Xi'an Jiaotong University, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Zhengzhou University, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite cardiovascular events (CCE)	Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction;rehospitalization rate	Change from Baseline at 1-year
Secondary	Frequency of angina pectoris per week	Frequency of angina pectoris	Change from Baseline frequency at 1 year
Secondary	Dosage of Nitroglycerin use per week	total dosage of nitroglycerin	Change from Baseline frequency and dosage at 1 year
Secondary	6-minute walking distance	6-minute walking distance	Change from Baseline distance at 1 year