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

Beijing Tsinghua Chang Gung Hospital

Status: Enrolling

Conditions: Postoperative Complications; Cerebrovascular Accident; Models; Major Adverse Cardiac Events

Treatments: Diagnostic Test: Revised Cardiac Risk Index

Study type: Observational

Funder types: Other

Identifiers

NCT06391632

ZB009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

positive event group

Description:

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);

Treatment:

Diagnostic Test: Revised Cardiac Risk Index

negative event group

Description:

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);

Treatment:

Diagnostic Test: Revised Cardiac Risk Index