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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

648 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Bypass Grafting Remote Ischemic Conditioning Ischemia-Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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RIC group

In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery.

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type DEVICE

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).

Control group

In the control group, a blood pressure cuff, same as the cuff in the RIC group, will be placed on both upper arms of the patients but only pressurized to 60 mmHg. The rest of the procedures will be the same.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No