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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03075124
Other study ID # SYSU8001
Secondary ID
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
Health authority
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

Study Design


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
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