- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075124
Effect of External Counter Pulsation on Coronary Artery Disease (ECP-CAD)
December 12, 2017 updated by: Guifu Wu, Eighth Affiliated Hospital, Sun Yat-sen University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guifu Wu, PhD
- Phone Number: +8615989893111
- Email: wuguifu@mail.sysu.edu.cn
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
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.
|
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)
Time Frame: Change from Baseline at 1-year
|
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
Time Frame: Change from Baseline frequency at 1 year
|
Frequency of angina pectoris
|
Change from Baseline frequency at 1 year
|
Dosage of Nitroglycerin use per week
Time Frame: Change from Baseline frequency and dosage at 1 year
|
total dosage of nitroglycerin
|
Change from Baseline frequency and dosage at 1 year
|
6-minute walking distance
Time Frame: Change from Baseline distance at 1 year
|
6-minute walking distance
|
Change from Baseline distance at 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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