Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03075124
Status:
UNKNOWN
Last Update Posted:
2017-12-13
First Post:
2017-02-28
Brief Title:
Effect of External Counter Pulsation on Coronary Artery Disease
Sponsor:
Eighth Affiliated Hospital Sun Yat-sen University
Organization:
Eighth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Effect of External Counter Pulsation on Coronary Artery Disease ECP-CAD
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECP-CAD
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None