Effect of External Counter Pulsation on Coronary Artery Disease
ECP-CAD
1 other identifier
interventional
380
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
June 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedDecember 13, 2017
December 1, 2017
12 months
February 28, 2017
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite cardiovascular events (CCE)
Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction；rehospitalization rate
Change from Baseline at 1-year
Secondary Outcomes (3)
Frequency of angina pectoris per week
Change from Baseline frequency at 1 year
Dosage of Nitroglycerin use per week
Change from Baseline frequency and dosage at 1 year
6-minute walking distance
Change from Baseline distance at 1 year
Study Arms (2)
External Counter Pulsation group
EXPERIMENTALA 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.
Control group
NO INTERVENTIONGuideline-driven standard medical treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of coronary artery disease;
- Signed informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University,
Xi’an, Shanxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 9, 2017
Study Start
June 8, 2018
Primary Completion
May 28, 2019
Study Completion
June 30, 2019
Last Updated
December 13, 2017
Record last verified: 2017-12