Clinical trial NCT06391632: Construction of a Prediction Model for MACCE in Elderly Patients After Elective Non-cardiac Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Adverse Cardiac Events
Cerebrovascular Accident
Postoperative Complications
Models
Keywords: Elderly patients
Elective non-cardiac surgery
MACCEs
Postoperative Complications
Selective Operation
predictive model
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 65 years of age undergoing elective non-cardiac surgery

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.

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.

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular event（MACCE）occurred in elderly patients after elective non-cardiac surgery
timeFrame: Within 3-7 days after surgery
Secondary outcomes:
measure: The Postoperative Quality of Recovery-15 scale (QoR-15)
timeFrame: Postoperative day 1 and postoperative day 3
measure: Other complications that occurred during postoperative hospitalization
timeFrame: Until three months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Huan Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: