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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06391632
Enrollment
3000
Registered
2024-04-30
Start date
2023-03-01
Completion date
2025-03-31
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTRevised 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.

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiac and Cerebrovascular event(MACCE)occurred in elderly patients after elective non-cardiac surgeryWithin 3-7 days after surgery1. 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);

Secondary

MeasureTime frameDescription
The Postoperative Quality of Recovery-15 scale (QoR-15)Postoperative day 1 and postoperative day 3The 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.
Other complications that occurred during postoperative hospitalizationUntil three months after surgeryRespiratory complications, lower extremity venous thrombosis/pulmonary embolism, renal failure, surgical site infection

Countries

China

Contacts

Primary ContactHuan Zhang, PhD
yhls01581@btch.edu.cn17800822861
Backup ContactHaolin Yin, MD
374916066@qq.com17738043809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026