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

NCT06391632 | Recruiting

• 1 other identifier: ZB009
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Elderly patients; Elective non-cardiac surgery; MACCEs; Postoperative Complications; Selective Operation; predictive model

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac and Cerebrovascular event（MACCE）occurred in elderly patients after elective non-cardiac 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 Outcomes (2)

• The Postoperative Quality of Recovery-15 scale (QoR-15)

  Postoperative day 1 and postoperative day 3

• Other complications that occurred during postoperative hospitalization

  Until three months after surgery

Study Arms (2)

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

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

Interventions

Revised Cardiac Risk Index 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.

Also known as: Frailty index scale, The Quality of Recovery-15 scale

negative event group; positive event group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 1000000, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke; Postoperative Complications

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huan Zhang, PhD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Zhang, PhD

CONTACT

17800822861; yhls01581@btch.edu.cn

Haolin Yin, MD

CONTACT

17738043809; 374916066@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 30, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-03

Locations

CN (1)