Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-02 @ 4:34 AM
Study NCT ID:
NCT06461468
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-06
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
Sponsor:
American Heart Association
Organization:
Study Overview
Official Title:
Detection of Hypertrophic Cardiomyopathy Using Electrocardiograms and Echocardiograms Through Federated Learning
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCM FLIP
Brief Summary:
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.
Detailed Description:
HCM FLIP (Hypertrophic Cardiomyopathy Federated Learning Implementation Platform) aim to build and test a model's system impact to detect hypertrophic cardiomyopathy (HCM) by training a machine learning (ML) model with electrocardiograms (ECGs) and echocardiograms (ECHOs). Approximately 10-1000 HCM cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. We hypothesize that a federated ML model will discriminate cases of HCM from those without HCM in a real-world setting.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: