Clinical trial NCT03075124: Effect of External Counter Pulsation on Coronary Artery Disease
Official title: Effect of External Counter Pulsation on Coronary Artery Disease (ECP-CAD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stable Chronic Angina
Coronary Artery Disease
Keywords: Coronary Artery Disease
external counter pulsation
major adverse cardiovascular events
Lead sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Second Affiliated Hospital of Zhengzhou University
name: Shanghai 10th People's Hospital
name: Xiangya Hospital of Central South University
First posted: 2017-03-09
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite cardiovascular events (CCE)
timeFrame: Change from Baseline at 1-year
Secondary outcomes:
measure: Frequency of angina pectoris per week
timeFrame: Change from Baseline frequency at 1 year
measure: Dosage of Nitroglycerin use per week
timeFrame: Change from Baseline frequency and dosage at 1 year
measure: 6-minute walking distance
timeFrame: Change from Baseline distance at 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Shang Hai
country: China
facility: Tenth People's Hospital of Tongji University
state: Shanghai
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University,
state: Shanxi
Study officials:
References: