Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE)

Coronary Artery Bypass Grafting Clinical Trial

— IMPROVE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141525
• Other study ID #: XJTU1AF2022LSK-427
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yang Yan
• Phone: +86.29.85323869
• Email: yangyan3[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 648
• Est. completion date: March 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Ischemia
• Remote Ischemic Conditioning

Intervention

Device:
• Remote ischemic conditioning
An automatic programmed blood pressure cuff will be placed on bilateral upper limbs of the patient and pressurized to 200 mmHg (or at least 20 mmHg above the systolic blood pressure), with 5 minutes of pressurization and 5 minutes of rest. One pressurization with rest is deemed as one cycle, and 4 cycles will be performed each time, for a total of 40 minutes.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiantong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-month after the enrollment.
Secondary	The incidence of all-cause of death	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3-month after the enrollment.
Secondary	The incidence of myocardial infarction	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3-month after the enrollment.
Secondary	The incidence of stroke	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3-month after the enrollment.
Secondary	The incidence of coronary revascularization surgery	The data will be obtained at 3-month follow-up, according to medical records of all patients.	3-month after the enrollment.
Secondary	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.	About 3 days after the operation.
Secondary	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.	About 7days after the operation.
Secondary	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.	3-month after the enrollment.