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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391632
• Other study ID #: ZB009
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Huan Zhang, PhD
• Phone: 17800822861
• Email: yhls01581[@]btch.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Accident
• Major Adverse Cardiac Events
• Postoperative Complications
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tsinghua Chang Gung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac and Cerebrovascular event(MACCE)occurred in elderly patients after elective non-cardiac surgery	all-cause death; non-fatal myocardial infarction/angina pectoris (new or recurring); non-fatal heart failure (new onset or recurrence); non-fatal cerebral infarction (new or reappeared); 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	The Postoperative Quality of Recovery-15 scale (QoR-15)	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
Secondary	Other complications that occurred during postoperative hospitalization	Respiratory complications, lower extremity venous thrombosis/pulmonary embolism, renal failure, surgical site infection	Until three months after surgery