Remote ischemic conditioning (RIC) is the process of repeated ischemia and reperfusion in the peripheral vessels, which is proved in reducing IRI in vital organs. This IMPROVE trial plans to enroll 648 patients who are diagnosed with coronary artery disease and are going to take off-pump CABG in five centers in China, to access whether RIC can and improve short-term prognosis.
Diagnosed with coronary artery disease and require off-pump CABG surgery.
Between 18 and 75 years old;
Normal left ventricular systolic function (ejection fraction >40%) and left ventricular end-diastolic internal diameter (<60 mm) in the cardiac ultrasound tests;
No or mild heart valve and great vessel abnormalities which do not require surgical intervention;
Severe tissue injuries.
Myalgia, fractures and other peripheral vascular lesions.
Bypass graft being the radial artery.
Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.
Parallel
Remote ischemic conditioning
DeviceAn automatic programmed blood pressure cuffs will be placed on two upper limbs of the patient and pressurized to 200 mmHg (or at least 20 mmHg higher than the systolic blood pressure if the systolic blood pressure of the patient is above 180 mmHg) with 5 minutes of pressurization and 5 minutes of rest. One pressurization with rest is deemed as one cycle (10 minutes), and 4 cycles will be performed each time (for a total of 40 minutes).
The incidence of MACCE
MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization surgery. The data will be obtained at 3-month follow-up, according to medical records of all patients.
The incidence of all-cause of death
The data will be obtained at 3-month follow-up, according to medical records of all patients.
The incidence of myocardial infarction
The data will be obtained at 3-month follow-up, according to medical records of all patients.
The incidence of stroke
The data will be obtained at 3-month follow-up, according to medical records of all patients.
The incidence of coronary revascularization surgery
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Total costs
Total costs include CABG surgery, medications, examinations, management of complications during the first hospitalization and subsequent hospital admissions for cardiovascular problems. The data will be obtained from medical records and 3-month follow-up.
The incidence of adverse events
Possible adverse events include ischemic pain, tissue damage (such as ulceration, gangrene), headache, bleeding events, neoplasm and accident (such as car accident, suicide) and etc. The data will be recorded from the medical records.
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital Xi'an Jiaotong University
Lead sponsor
Beijing Anzhen Hospital
Collaborator
People's Hospital of Qinghai Province
Collaborator
The Second Hospital of Yulin City
Collaborator
Baoji Central Hospital
Collaborator
