NCT06287892

Brief Summary

The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 8, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

April 8, 2023

Last Update Submit

March 4, 2024

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of HCM with AI-ECG

    First a diagnosis of HCM is made as the standard outcome according to 1) an International Classification of Diseases (ICD) code for HCM (ICD-9425.1, 425.11, 425.18, and ICD10 I42.1, I42.2); 2) reports from the echocardiographers. An AI-ECG algorithm will be used to make a diagnosis of HCM and compared with the standard outcome. The performance of the AI-ECG algorithm will be evaluated with metrics including AU-ROC, specificity, sensitivity and F1 value.

    1 year within the time frame of ECG data collection

Study Arms (2)

HCM group

Patients diagnosed with HCM

Control group

Subjects without HCM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes patients with HCM, and subjects without HCM as control.

You may qualify if:

  • Diagnosed with HCM

You may not qualify if:

  • Patients with ventricular pacing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Yixiu Liang, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yixiu Liang, MD

CONTACT

+8613764653847liang.yixiu@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cardiology

Study Record Dates

First Submitted

April 8, 2023

First Posted

March 1, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)