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

NCT06141525 | Recruiting

• 1 other identifier: XJTU1AF2022LSK-427-01
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Grafting; Remote Ischemic Conditioning; Ischemia-Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The incidence of all-cause of death

  3-month after the enrollment.

• The incidence of myocardial infarction

  3-month after the enrollment.

• The incidence of stroke

  3-month after the enrollment.

• The incidence of coronary revascularization surgery

  3-month after the enrollment.

• The length of postoperative ICU-stay

  About 3 days after the operation.

Other Outcomes (2)

• Total costs

  3-month after the enrollment.

• The incidence of adverse events

  3-month after the enrollment.

Study Arms (2)

RIC group

EXPERIMENTAL

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

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.

Interventions

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).

RIC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Beijing Anzhen Hospital: collaborator
• People's Hospital of Qinghai Province: collaborator
• The Second Hospital of Yulin City: collaborator
• Baoji Central Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38616242 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yan

CONTACT

+86.29.85323869; yangyan3@xjtu.edu.cn

Li Guoliang

CONTACT

+86.29.85323869; liguoliang_med@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)