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

NCT ID: NCT06391632

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

positive event group

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);

Revised Cardiac Risk Index

Intervention Type: DIAGNOSTIC_TEST

The Revised Cardiac Risk Index (RCRI) attempts to estimate the likelihood of cardiac complications during hospitalization in patients undergoing noncardiac surgery.The Frailty Index is a commonly used tool in clinical practice to assess the degree of frailty in patients.The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery.

negative event group

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);

Revised Cardiac Risk Index

Intervention Type: DIAGNOSTIC_TEST

The Revised Cardiac Risk Index (RCRI) attempts to estimate the likelihood of cardiac complications during hospitalization in patients undergoing noncardiac surgery.The Frailty Index is a commonly used tool in clinical practice to assess the degree of frailty in patients.The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery.

Interventions

Revised Cardiac Risk Index

The Revised Cardiac Risk Index (RCRI) attempts to estimate the likelihood of cardiac complications during hospitalization in patients undergoing noncardiac surgery.The Frailty Index is a commonly used tool in clinical practice to assess the degree of frailty in patients.The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Frailty index scale; The Quality of Recovery-15 scale

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huan Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Locations

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huan Zhang, PhD

Role: CONTACT

yhls01581@btch.edu.cn

17800822861

Haolin Yin, MD

Role: CONTACT

374916066@qq.com

17738043809

Facility Contacts

Yin MD, HaoIin

Role: primary

374916066@qq.com

Other Identifiers

ZB009

Identifier Type: -

Identifier Source: org_study_id