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

April 25, 2024 updated by: Beijing Tsinghua Chang Gung Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 1000000
        • Recruiting
        • Beijing Tsinghua Chang Gung Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over 65 years of age undergoing elective non-cardiac surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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);
Diagnostic test: 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.
Other Names:
  • Frailty index scale
  • The Quality of Recovery-15 scale
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);
Diagnostic test: 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.
Other Names:
  • Frailty index scale
  • The Quality of Recovery-15 scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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);
Within 3-7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Postoperative Quality of Recovery-15 scale (QoR-15)
Time Frame: 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.
Postoperative day 1 and postoperative day 3
Other complications that occurred during postoperative hospitalization
Time Frame: Until three months after surgery
Respiratory complications, lower extremity venous thrombosis/pulmonary embolism, renal failure, surgical site infection
Until three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Investigators

  • Principal Investigator: Huan Zhang, PhD, Beijing Tsinghua Changgeng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZB009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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