Clinical trial NCT06141525: Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting
Official title: Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE): A National, Multi-center, Randomized, Controlled, Open-label, Blinded-endpoint Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Remote Ischemic Conditioning
Ischemia-Reperfusion Injury
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: People's Hospital of Qinghai Province
name: The Second Hospital of Yulin City
name: Baoji Central Hospital
First posted: 2023-11-21
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: The incidence of MACCE
timeFrame: 3-month after the enrollment.
Secondary outcomes:
measure: The incidence of all-cause of death
timeFrame: 3-month after the enrollment.
measure: The incidence of myocardial infarction
timeFrame: 3-month after the enrollment.
measure: The incidence of stroke
timeFrame: 3-month after the enrollment.
measure: The incidence of coronary revascularization surgery
timeFrame: 3-month after the enrollment.
measure: The length of postoperative ICU-stay
timeFrame: About 3 days after the operation.
measure: The total length of stay in the hospital
timeFrame: About 7days after the operation.
measure: Changes of 6-min walk test results
timeFrame: 3-month after the enrollment.
Other outcomes:
measure: Total costs
timeFrame: 3-month after the enrollment.
measure: The incidence of adverse events
timeFrame: 3-month after the enrollment.
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: