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Recruiting NCT06141525

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

No phase Interventional Coronary Artery Bypass Grafting Remote Ischemic Conditioning Ischemia-Reperfusion Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote ischemic conditioning.
Who it may be relevant to
Registry conditions: Coronary Artery Bypass Grafting, Remote Ischemic Conditioning, Ischemia-Reperfusion Injury. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • Device 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).

Primary outcome measures

  • The incidence of MACCE [Time frame: 3-month after the enrollment.]
Secondary outcome measures (7)
  • The incidence of all-cause of death [Time frame: 3-month after the enrollment.]
  • The incidence of myocardial infarction [Time frame: 3-month after the enrollment.]
  • The incidence of stroke [Time frame: 3-month after the enrollment.]
  • The incidence of coronary revascularization surgery [Time frame: 3-month after the enrollment.]
  • The length of postoperative ICU-stay [Time frame: About 3 days after the operation.]
  • The total length of stay in the hospital [Time frame: About 7days after the operation.]
  • Changes of 6-min walk test results [Time frame: 3-month after the enrollment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • First Affiliated Hospital of Xi'an Jiantong University — Xi'an

Publications

  • 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

Identifiers

NCT: NCT06141525 · XJTU1AF2022LSK-427-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗