NCT07259837

Brief Summary

Using prospectively collected clinical data from the Chinese Perioperative Database of Elderly Patients, this study retrospectively analyzed patients aged ≥65 years who underwent elective non-cardiac, non-neurosurgical procedures under general anesthesia between April 2020 and April 2022. The study examined the associations between various preoperative health and functional status assessment tools and the occurrence of cardiovascular and cerebrovascular complications within 30 days after surgery, aiming to compare the clinical value of different assessment instruments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,751

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

November 21, 2025

Last Update Submit

December 7, 2025

Conditions

Keywords

Functional statusQuality of lifeMajor Adverse Cardiac and Cerebrovascular EventsOlder adults

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was the occurrence of MACCE within 30 days after surgery.

    The primary outcome was the occurrence of MACCE within 30 days after surgery, defined as any of the following: stroke, myocardial infarction, angina pectoris, congestive heart failure, cardiac arrest, or all-cause mortality.\[33\] Postoperative complications were systematically assessed on days 1-5, 7, and 30, and continued until discharge. For discharged patients, outcomes were recorded via telephone follow-up, with diagnoses from the treating hospital. For MACCE, postoperative medical records of hospitalized patients were thoroughly reviewed according to the follow-up schedule, including serial measurements of serum myocardial injury biomarkers, electrocardiograms, echocardiograms, coronary angiography findings, postoperative progress notes, consultation records, and expert diagnostic evaluations.

    Within 30 days after surgery.

Study Arms (1)

A retrospective cohort study based on prospectively collected data.

Patients were divided into the MACCE group and the non-MACCE group according to the occurrence of major adverse cardiac and cerebrovascular events within 30 days after surgery.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were interviewed one day before surgery and completed a comprehensive preoperative functional status and quality of life assessment, which included the Basic Activities of Daily Living (BADL), Instrumental Activities of Daily Living (IADL), EuroQol Five-Dimension Five-Level (EQ-5D-5L), Metabolic Equivalent of Task (MET), and FRAIL scale.

You may qualify if:

  • Aged ≥65 years;
  • Scheduled for elective non-cardiac, non-neurosurgical procedures;
  • Consented to undergo preoperative functional status and quality of life assessments.

You may not qualify if:

  • Had severe dementia, language disorders, significant hearing or visual impairments, or were in a coma;
  • Had Mini-Mental State Examination (MMSE) scores below the established educational thresholds: \<18 for illiterate individuals, \<21 for those with primary education (≤6 years), and \<25 for those with secondary education or higher (\>6 years);
  • Underwent local anesthesia or monitored anesthesia care;
  • Had an operative time ≤30 minutes;
  • Incompleted all the designated functional status and quality of life assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of administration, Anesthesiology

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 2, 2025

Study Start

April 1, 2020

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

December 9, 2025

Record last verified: 2025-12

Locations