Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06141525

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

Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2024-07-12

648

Participants Needed

1

Research Sites

279 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital Xi'an Jiaotong University

Lead Sponsor

B

Beijing Anzhen Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with coronary artery disease and require off-pump CABG surgery.
  • Between 18 and 75 years old.
  • Normal left ventricular systolic function with ejection fraction greater than 40% and left ventricular end-diastolic internal diameter less than 60 mm on cardiac ultrasound.
  • No or mild heart valve and great vessel abnormalities not requiring surgical intervention.
  • Participants or their authorized relatives agree to participate and sign informed consent.
Not Eligible

You will not qualify if you...

  • Severe tissue injuries.
  • Myalgia, fractures, or other peripheral vascular lesions.
  • Bypass graft using the radial artery.
  • Stenosis or severe malformations of subclavian, jugular, or femoral arteries and veins.
  • Previous vagus nerve trunk dissection or vagus nerve block surgery.
  • Other surgical operations at the same time.
  • Pre-existing severe cardiac insufficiency, acute coronary syndromes, malignant hypertension, or cardiogenic shock.
  • Severe coagulation abnormalities or severe anemia.
  • Severe mental disorders.
  • Malignant tumors.
  • Pregnant or lactating.
  • Increased risk of treatment as assessed by investigators.
  • Refusal to sign informed consent form.

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, China, 710061

Actively Recruiting

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Research Team

Y

Yang Yan

CONTACT

L

Li Guoliang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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