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Clinical Trials/NCT06391632
NCT06391632
Recruiting
Not Applicable

Construction of a Prediction Model for Severe Cardiovascular and Cerebrovascular Complications in Elderly Patients After Elective Non-cardiac Surgery: a Prospective Cohort Study

Beijing Tsinghua Chang Gung Hospital1 site in 1 country3,000 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Adverse Cardiac Events
Sponsor
Beijing Tsinghua Chang Gung Hospital
Enrollment
3000
Locations
1
Primary Endpoint
Major Adverse Cardiac and Cerebrovascular event(MACCE)occurred in elderly patients after elective non-cardiac surgery
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in elderly patients. With the aging population and the large proportion of elderly patients undergoing non-cardiac surgery, it is increasingly important to establish a prediction model for postoperative severe cardiovascular and cerebrovascular events in elderly patients undergoing noncardiac surgery.

Detailed Description

This project intends to use a multi-center, prospective cohort study method to include about 3000 elderly patients over 65 years old who are planning to undergo non-cardiac surgery, collect relevant data before, during and after surgery, observe the occurrence of serious cardiovascular and cerebrovascular complications in the perioperative period, establish a "MACCE risk prediction model for elderly patients after elective non-cardiac surgery", and verify its effectiveness and reliability. The results of this study will help to improve the predictive ability of postoperative complications of severe cardiovascular and cerebrovascular events in elderly patients undergoing elective non-cardiac surgery, which is conducive to early risk assessment, risk classification, strengthening perioperative patient management, reducing the incidence of postoperative MACCE, and improving the prognosis of elderly patients.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
March 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The subjects were patients with elective non-cardiac surgery;
  • Older than 65 years;
  • Patients signed informed consent.

Exclusion Criteria

  • The anesthesia should be received in any of the following ways: local anesthesia;
  • local anesthesia enhancement, and simple nerve block anesthesia;
  • Patients who are scheduled to undergo day surgery;
  • Expected operation time \<1 hour for patients;
  • Patients who are expected to stay in hospital for less than 3 days after surgery;
  • Patients who refuse to enroll.

Outcomes

Primary Outcomes

Major Adverse Cardiac and Cerebrovascular event(MACCE)occurred in elderly patients after elective non-cardiac surgery

Time Frame: Within 3-7 days after surgery

1. all-cause death; 2. non-fatal myocardial infarction/angina pectoris (new or recurring); 3. non-fatal heart failure (new onset or recurrence); 4. non-fatal cerebral infarction (new or reappeared); 5. new or recurrent malignant arrhythmias (ventricular tachycardia/ventricular fibrillation, atrial flutter/atrial fibrillation, hemodynamically unstable second/third degree atrioventricular block);

Secondary Outcomes

  • Other complications that occurred during postoperative hospitalization(Until three months after surgery)
  • The Postoperative Quality of Recovery-15 scale (QoR-15)(Postoperative day 1 and postoperative day 3)

Study Sites (1)

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