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Clinical Trials/NCT05121610
NCT05121610
Unknown
Not Applicable

Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease

Beijing Anzhen Hospital0 sites2,864 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Beijing Anzhen Hospital
Enrollment
2864
Primary Endpoint
MACCE
Last Updated
4 years ago

Overview

Brief Summary

Coronary heart disease is one of the most serious diseases that endanger people's health. Complex coronary artery disease is critical and has high mortality. Therefore, it is urgent to explore the best treatment method for complex coronary artery disease. Some previous studies have shown that patients with left main coronary artery disease with a SYNTAX score> 32 points, and diabetic/non-diabetic three-vessel disease patients with coronary heart disease with a SYNTAX score > 22 points, CABG is recommended for revascularization. However, with the continuous innovation of surgical technology and the rapid development of surgical instruments, the treatment of patients with complex coronary artery disease is increasing. Therefore, it is necessary to investigate the effects of different revascularization strategies on long-term prognosis in patients with complex coronary artery disease (SYNTAX score > 22 points).

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
September 1, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Anzhen Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yujie Zhou

Principal Investigator

Beijing Anzhen Hospital

Eligibility Criteria

Inclusion Criteria

  • Male/female aged 18-80 years;
  • Having complex coronary artery disease (SYNTAX score \> 22 points) undergoing myocardial revascularization

Exclusion Criteria

  • Cardiogenic shock or hemodynamic instability;
  • Undergoing other heart surgery at the same time;
  • Previous coronary artery bypass surgery;
  • History of cerebral hemorrhage;
  • Ischemic stroke in the past six months;
  • History of cancer;
  • Life expectancy no more than 12 months

Outcomes

Primary Outcomes

MACCE

Time Frame: 1 year

Major adverse cardiovascular and cerebrovascular events (MACCE) at 1 year, including all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, and non-fatal stroke

Secondary Outcomes

  • The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke(1 year)
  • Cardiovascular death(1 year)
  • All cause death(1 year)
  • The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization(1 year)
  • All bleeding events defined by the BARC bleeding criteria(1 year)
  • The composite endpoints including cardiovascular death or nonfatal myocardial infarction(1 year)
  • Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria(1 year)
  • Non-fatal myocardial infarction(1 year)
  • Non-fatal stroke(1 year)
  • Ischemia-driven revascularization(1 year)

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