Effect of External Counter Pulsation on Coronary Artery Disease
- Conditions
- Coronary Artery DiseaseStable Chronic Angina
- Interventions
- Device: External Counter Pulsation
- Registration Number
- NCT03075124
- Lead Sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 380
- Clinical diagnosis of coronary artery disease;
- Signed informed consent.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description External Counter Pulsation group 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.
- Primary Outcome Measures
Name Time Method composite cardiovascular events (CCE) Change from Baseline at 1-year Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction；rehospitalization rate
- Secondary Outcome Measures
Name Time Method Dosage of Nitroglycerin use per week Change from Baseline frequency and dosage at 1 year total dosage of nitroglycerin
6-minute walking distance Change from Baseline distance at 1 year 6-minute walking distance
Frequency of angina pectoris per week Change from Baseline frequency at 1 year Frequency of angina pectoris
Trial Locations
- Locations (4)
Tenth People's Hospital of Tongji University
🇨🇳Shang Hai, Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University,
🇨🇳Xi'an, Shanxi, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China