Construction of a Prediction Model for MACCE in Elderly Patients After Elective Non-cardiac Surgery

Recruiting

• Conditions: Postoperative Complications; Major Adverse Cardiac Events; Cerebrovascular Accident; Models
• Interventions: Diagnostic Test: Revised Cardiac Risk Index

• Registration Number: NCT06391632
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-03
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
positive event group	Revised Cardiac Risk Index	The following complications occur 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);
negative event group	Revised Cardiac Risk Index	The following complications did not occur 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);

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular event（MACCE）occurred in elderly patients after elective non-cardiac surgery	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 Outcome Measures

Name	Time	Method
Other complications that occurred during postoperative hospitalization	Until three months after surgery	Respiratory complications, lower extremity venous thrombosis/pulmonary embolism, renal failure, surgical site infection
The Postoperative Quality of Recovery-15 scale (QoR-15)	Postoperative day 1 and postoperative day 3	The Postoperative Quality of Recovery-15 scale (QoR-15) on the 1st and 3rd postoperative days.The Postoperative Quality of Recovery-15 scale (QoR-15) on the 1st and 3rd postoperative days. The score ranges from 0 to 150, with higher scores indicating better postoperative recovery.

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China