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.
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. However, the effect of RIC in patients undergoing off-pump CABG is still unclear. 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. Patients will be randomly assigned into RIC group and control group. The primary outcome is the occurrence of the major adverse cardiovascular and cerebrovascular events (MACCE) within the 3-month follow-up. The MACCE is defined as all-cause of death, myocardial infarction, stroke and coronary revascularization surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
648
An 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).
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, China
RECRUITINGThe 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.
Time frame: 3-month after the enrollment.
The incidence of all-cause of death
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Time frame: 3-month after the enrollment.
The incidence of myocardial infarction
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Time frame: 3-month after the enrollment.
The incidence of stroke
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Time frame: 3-month after the enrollment.
The incidence of coronary revascularization surgery
The data will be obtained at 3-month follow-up, according to medical records of all patients.
Time frame: 3-month after the enrollment.
The length of postoperative ICU-stay
This outcome includes all days in ICU after the operation of all patients. The data will be recorded from the medical records.
Time frame: About 3 days after the operation.
The total length of stay in the hospital
This outcome includes all days in the hospital of all patients. The data will be recorded from the medical records.
Time frame: About 7days after the operation.
Changes of 6-min walk test results
6-min walk test will be measured by stopwatches and metre rulers. The test assesses the overall response of all systems involved in exercise by measuring the distance the patient walks rapidly on a flat, hard surface over a period of six minutes.
Time frame: 3-month after the enrollment.
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