NCT06119009

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
281,497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

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, 2008

Completed
11.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

11.6 years

First QC Date

October 25, 2023

Last Update Submit

October 31, 2023

Conditions

Heart BlockRisk Factor

Keywords

Postoperative new-onset heart blocksNoncardiac surgeryMachine learningPrediction modelPrognosis

Outcome Measures

Primary Outcomes (1)

  • New-onset heart blocks

    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

Study Arms (2)

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

Interventions

non interventionsOTHER
Heart blocksNon- Heart blocks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • surgical duration of less than 30 minutes
  • incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic 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
Director

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 7, 2023

Study Start

January 1, 2008

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

November 7, 2023

Record last verified: 2023-10