Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting (IMPROVE)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RIC group In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery. |
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.
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- The incidence of all-cause of death [3-month after the enrollment.]
The data will be obtained at 3-month follow-up, according to medical records of all patients.
- The incidence of myocardial infarction [3-month after the enrollment.]
The data will be obtained at 3-month follow-up, according to medical records of all patients.
- The incidence of stroke [3-month after the enrollment.]
The data will be obtained at 3-month follow-up, according to medical records of all patients.
- The incidence of coronary revascularization surgery [3-month after the enrollment.]
The data will be obtained at 3-month follow-up, according to medical records of all patients.
- The length of postoperative ICU-stay [About 3 days after the operation.]
This outcome includes all days in ICU after the operation of all patients. The data will be recorded from the medical records.
- The total length of stay in the hospital [About 7days after the operation.]
This outcome includes all days in the hospital of all patients. The data will be recorded from the medical records.
- Changes of 6-min walk test results [3-month after the enrollment.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with coronary artery disease and require off-pump CABG surgery.
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Between 18 and 75 years old;
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Normal left ventricular systolic function (ejection fraction >40%) and left ventricular end-diastolic internal diameter (<60 mm) in the cardiac ultrasound tests;
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No or mild heart valve and great vessel abnormalities which do not require surgical intervention;
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Participants or their authorized relatives agree to participate in the clinical trial and sign the informed consent.
Exclusion Criteria:
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Severe tissue injuries.
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Myalgia, fractures and other peripheral vascular lesions.
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Bypass graft being the radial artery.
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Stenosis or severe malformations of the subclavian, jugular and femoral arteries and veins.
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Previous vagus nerve trunk dissection or vagus nerve block surgery.
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Other surgical operations at the same time.
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Patients with pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension and cardiogenic shock.
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Severe coagulation abnormality or severe anemia.
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Severe mental disorder.
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Malignant tumors.
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Pregnant or lactating.
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Increased risk of treatment for patients, according to investigators.
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Refuse to sign the informed consent form.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xi'an Jiantong University | Xi'an | Shaanxi | China | 710061 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
Investigators
- Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJTU1AF2022LSK-427