Heart BlockNCT06119009
New-onset Heart Blocks After Noncardiac Surgery: a Retrospective Study of More Than 280,000 Patients
An observational study of Heart Block and Risk Factor, run by Chinese PLA General Hospital.
Trial summary
This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Block, Risk Factor
- What is being tested?
- non interventions
- How many people
- 281,497 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- surgical duration of less than 30 minutes
- incomplete data
About this study
This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.
Read the 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).
- Conditions
- Heart Block, Risk Factor
- Being tested
- non interventions
- Keywords
- Postoperative new-onset heart blocks, Noncardiac surgery, Machine learning, Prediction model, Prognosis
- Medical subject headings
- Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventionsOther
| Study group | Role | What they receive |
|---|---|---|
| Non- Heart blocks | The number of patients who did not suffered the heart blocks in the postoperative 1-year period Receives: Other: non interventions | |
| Heart blocks | The number of patients who suffered the heart blocks in the postoperative 1-year period Receives: Other: non interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2008
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart BlockStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 281,497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119009
- Sponsor's protocol ID
- ChinesePLAGH301NBBB
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New-onset Heart Blocks After Noncardiac Surgery: a Retrospective Study of More Than 280,000 Patients
- ClinicalTrials.gov ID
- NCT06119009
- Acronym / sponsor ID
- ChinesePLAGH301NBBB
- Conditions
- Heart Block, Risk Factor
- Keywords
- Postoperative new-onset heart blocks, Noncardiac surgery, Machine learning, Prediction model, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281,497 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non- Heart blocks | – | Other: non interventionsThe number of patients who did not suffered the heart blocks in the postoperative 1-year period |
| Heart blocks | – | Other: non interventionsThe number of patients who suffered the heart blocks in the postoperative 1-year period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- surgical duration of less than 30 minutes
- incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventions | Other | Heart blocks, Non- Heart blocks |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Block and Risk Factor, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New-onset heart blocks (time frame: within one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.