NCT06884436

Brief Summary

This cohort study aims to determine when preoperative cardiology consultation is needed to reduce the incidence of major adverse cardiac events (MACE) in elderly patients undergoing non-cardiac surgery. The study collected data on elderly patients with preoperative electrocardiogram (ECG) results who underwent non-cardiac surgery. It was conducted at the First Medical Center of the Chinese People's Liberation Army General Hospital from January 2015 to August 2019. MACE was defined as a composite event occurring within 30 days postoperatively, including acute myocardial infarction, unstable angina, heart failure, new-onset severe arrhythmias, non-fatal cardiac arrest, and cardiac death. Data were extracted using structured query language (SQL) and reviewed by three experienced clinicians. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated. Additionally, the study aimed to identify which categories of ECG findings necessitate cardiology consultation to reduce the incidence of adverse cardiac events, thereby optimizing the cardiology consultation process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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

January 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

March 13, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

Cardiology ConsultationMajor Adverse Cardiac EventsPreoperativeelderlyelectrocardiogram

Outcome Measures

Primary Outcomes (1)

  • MACE

    The entire sample was divided into a development cohort and a validation cohort in a 7:3 ratio. Univariate and multivariate logistic regression analyses were conducted to identify risk predictors of MACE and to establish a nomogram with statistically significant predictors. The development cohort was used to construct the MACE prediction model, while the data from the validation cohort were used for validation. Preoperative cardiology consultation was considered as a mediating variable. By modeling, the confounding factors and risk factors for MACE were identified, and the impact of cardiology consultation as a mediating factor on the incidence of postoperative MACE was evaluated.

    within 30 days post-surgery

Study Arms (1)

Risk Predictors of Major Adverse Cardiac Events

Identify risk factors through the incidence of major adverse cardiac events occurring within 30 days post-surgery, and analyze the benefits to patients through the intervention of cardiology consultations.

Eligibility Criteria

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

Select elderly patients who underwent elective surgery at the First Medical Center of the PLA General Hospital from January 2015 to August 2019. All subjects will sign an informed consent form; patients who cannot sign the informed consent form will be provided with verbal informed consent.

You may qualify if:

  • Age ≥ 65 years;
  • Preoperative ECG results available.

You may not qualify if:

  • Age \< 65 years;
  • Accepted cardiac or neuro surgery;
  • Second surgery within 30 days post-operation;
  • Patient refused to follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, The First Medical Center, Chinese PLA General Hospital

Beijing, China

Location

Related Publications (3)

  • Beattie WS, Lalu M, Bocock M, Feng S, Wijeysundera DN, Nagele P, Fleisher LA, Kurz A, Biccard B, Leslie K, Howell S, Landoni G, Grocott H, Lamy A, Richards T, Myles P; StEP COMPAC Group; Patient Comfort; Clinical Indicators; Delirium Postoperative Cognitive Dysfunction Stroke; Cardiovascular; Data Extractors; Respiratory; Inflammation Sepsis; Acute Kidney Injury; Bleeding Complications Patient Blood Management; Healthcare Resource Utilisation; Patient-Centred Outcomes; Organ Failure and Survival; Cancer Surgery. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes. Br J Anaesth. 2021 Jan;126(1):56-66. doi: 10.1016/j.bja.2020.09.023. Epub 2020 Oct 20.

  • Smilowitz NR, Berger JS. Perioperative Cardiovascular Risk Assessment and Management for Noncardiac Surgery: A Review. JAMA. 2020 Jul 21;324(3):279-290. doi: 10.1001/jama.2020.7840.

  • Hao L, Xu X, Dupre ME, Guo A, Zhang X, Qiu L, Zhao Y, Gu D. Adequate access to healthcare and added life expectancy among older adults in China. BMC Geriatr. 2020 Apr 9;20(1):129. doi: 10.1186/s12877-020-01524-9.

MeSH Terms

Conditions

Cardiovascular DiseasesDeath, Sudden, CardiacHeart ArrestArrhythmias, CardiacHeart FailureAngina, Unstable

Condition Hierarchy (Ancestors)

Heart DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsAngina PectorisMyocardial IschemiaVascular DiseasesChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jingsheng Lou, PhD & MD

    The First Medical Center, Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

January 1, 2015

Primary Completion

August 31, 2019

Study Completion

December 31, 2019

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Given the sensitive nature of the questions posed in this study, we assured participants that their raw data would remain confidential. Therefore, the raw numerical data used to extrapolate the graphs/charts are not present within the manuscript and will not be disclosed. These data will be shared upon reasonable request made to the corresponding author.

Locations