New-onset Heart Blocks After Noncardiac Surgery: a Retrospective Study of More Than 280,000 Patients

October 31, 2023 updated by: Hao Li, Chinese PLA General Hospital
This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

Methods: A retrospective cohort study included 281,497 patients aged 18 or older who underwent noncardiac surgery at a single center between Jan 2008 and Aug 2019. The main outcome was postoperative new-onset heart blocks within one year, including atrioventricular and bundle blocks. Prognostic impact was assessed using Kaplan-Meier survival curves and time-dependent Cox regression analysis. Perioperative data was used for machine learning models (logistic regression, support vector machine, random forest, decision tree). Model performance was measured using the area under the receiver operating characteristic curve (AUC).

Study Type

Observational

Enrollment (Actual)

281497

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data were gathered from electronic medical records (EMRs) for all patients undergoing noncardiac surgery at the First Medical Center of the Chinese People's Liberation Army General Hospital (PLAGH) from January 1, 2008 to August 1, 2019. Patients with a surgical duration of less than 30 minutes or age <18 years were excluded. Input data elements were extracted from the patient anesthesia and medical records. The survival data one year after surgery were obtained from medical records and telephone follow-up records confirmed by the Chinese Center for Disease Control and Prevention (CCDC)

Description

Inclusion Criteria:

  • patients above 18 yrs undergoing noncardiac surgery at the First Medical Center of the Chinese People's Liberation Army General Hospital (PLAGH) from January 1, 2008 to August 1, 2019.

Exclusion Criteria:

  • surgical duration of less than 30 minutes
  • incomplete data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non- Heart blocks
The number of patients who did not suffered the heart blocks in the postoperative 1-year period
Other: non interventions
Heart blocks
The number of patients who suffered the heart blocks in the postoperative 1-year period
Other: non interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New-onset heart blocks
Time Frame: within one year after surgery
The number of new-onset heart blocks within one year after surgery, including first-, second-, and third-degree AV blocks and left- and right-branch bundle blocks
within one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinesePLAGH301NBBB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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