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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Stable Chronic Angina
• Intervention / Treatment: Device: External Counter Pulsation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 380
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The Second Affiliated Hospital of Zhengzhou University
      • Contact: Hui Zhang, MD; Phone Number: +86 13298322770
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Tianlun Yang, MD; Phone Number: +8613707315500
  • Shanghai
    • Shang Hai, Shanghai, China
      • Recruiting
      • Tenth People's Hospital Of Tongji University
      • Contact: Weiming Li, MD; Phone Number: +86 18917683469
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University,
      • Contact: Yongqin Li, MD; Phone Number: +86 13572107879
      • Principal Investigator: Xi Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: External Counter Pulsation group; 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.	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.
NO_INTERVENTION: Control group; Guideline-driven standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite cardiovascular events (CCE)	Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction；rehospitalization rate	Change from Baseline at 1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of angina pectoris per week	Frequency of angina pectoris	Change from Baseline frequency at 1 year
Dosage of Nitroglycerin use per week	total dosage of nitroglycerin	Change from Baseline frequency and dosage at 1 year
6-minute walking distance	6-minute walking distance	Change from Baseline distance at 1 year

Collaborators and Investigators

• Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Xiangya Hospital of Central South University; Shanghai 10th People's Hospital; Second Affiliated Hospital of Zhengzhou University; Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 8, 2018
• Primary Completion (ANTICIPATED): May 28, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (ACTUAL): March 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; major adverse cardiovascular events; external counter pulsation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina, Stable
• Other Study ID Numbers: SYSU8001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No