Remote ischemic conditioning: 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).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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;
* Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.
Exclusion Criteria:
* 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.
* Previous vagus nerve trunk dissection or vagus nerve block surgery.
* Other surgical operations at the same time.
* Patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock.
* Severe coagulation abnormality or severe anemia.
* Severe mental disorder.
* Malignant tumors.
* Pregnant or lactating.
* Increased risk of treatment for patients, according to investigators.
* Refuse to sign the informed consent form.
Primary outcome measure(s)
The incidence of MACCE — 3-month after the enrollment. 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.
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Xi'an Jiantong University
Xi'an
Shaanxi
Recruiting
More First Affiliated Hospital Xi'an Jiaotong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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