NCT05967546

Brief Summary

This study aims to design and train a deep learning model for the diagnosis of different arrhythmias.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress34%
Dec 2024Dec 2028

First Submitted

Initial submission to the registry

July 6, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 30, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

July 6, 2023

Last Update Submit

April 2, 2024

Conditions

Keywords

Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • A deep learning model designed to intelligently identify the types of arrhythmia.

    The model is trained on the training set, the best model and hyperparameters are selected through the verification set, and finally the model results are tested on the test set.

    1 day after the enrollment.

Secondary Outcomes (1)

  • The sensitivity, specificity and accuracy of the deep learning model

    1 day after the enrollment.

Study Arms (1)

Experimental Group

ECG data and clinical data from this group of arrhythmia patients will be used to build a deep learning model.

Other: Observational

Interventions

No interventions will be given to patients.

Experimental Group

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with arrhythmia by twelve-lead electrocardiogram or Holter.

You may qualify if:

  • For retrospective study: 1.Patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or Holter; 2.The type of arrhythmia is diagnosed by intracardiac electrophysiological examination.
  • For prospective study: 1.Patients with arrhythmia diagnosed by routine surface 12-lead electrocardiogram or Holter; 2.Intracardiac electrophysiological examination is planned.

You may not qualify if:

  • Lack of routine surface 12-lead electrocardiogram or holter data;
  • Lack of intracardiac electrophysiological examination;
  • Patients refused to sign informed consent and refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Guoliang Li, M.D.

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li, M.D.

CONTACT

Chaofeng Sun, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 1, 2023

Study Start

December 30, 2024

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations