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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| People's Hospital of Qinghai Province | UNKNOWN |
| The Second Hospital of Yulin City | UNKNOWN |
| Baoji Central Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC group | Experimental | In the RIC group, patients will undergo RIC training in the 3 days before and 7 days after the CABG surgery. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| The incidence of myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Total costs | Total costs include CABG surgery, medications, examinations, management of complications during the first hospitalization and subsequent hospital admissions for cardiovascular problems. The data will be obtained from medical records and 3-month follow-up. | 3-month after the enrollment. |
| The incidence of adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yan | Contact | +86.29.85323869 | yangyan3@xjtu.edu.cn | |
| Li Guoliang | Contact | +86.29.85323869 | liguoliang_med@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Yan | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiantong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38616242 | Derived | Yan Y, Zhao C, Niu J, Yan P, Li J, Wang D, Li G. Rationale and Design of the IMPROVE Trial: A Multicenter, Randomized, Controlled, Open-label, Blinded-endpoint Trial Assessing the Efficacy of Remote Ischemic Conditioning in Patients Undergoing Off-Pump Coronary Artery Bypass Grafting. Adv Ther. 2024 Jul;41(7):3003-3012. doi: 10.1007/s12325-024-02836-7. Epub 2024 Apr 15. |
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| OTHER |
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The data will be obtained at 3-month follow-up, according to medical records of all patients.
| 3-month after the enrollment. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Possible adverse events include ischemic pain, tissue damage (such as ulceration, gangrene), headache, bleeding events, neoplasm and accident (such as car accident, suicide) and etc. The data will be recorded from the medical records. |
| 3-month after the enrollment. |
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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