Clinical trial NCT06461468: Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
Official title: Detection of Hypertrophic Cardiomyopathy Using Electrocardiograms and Echocardiograms Through Federated Learning
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypertrophic Cardiomyopathy
Keywords: HCM
Hypertrophic Cardiomyopathy
Federated Learning
Federated Learning Platform
FLP
Lead sponsor: American Heart Association
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollment Target:

Phase 1: Approximately 10-100 HCM cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. Since a larger sample size benefits training ML models, additional cases could be included based on availability within each institution.

Phase 2: Institution-specific cohort of patients (see Section 7.4.2) to simulate implementation of the algorithm; natural case control ratio and consecutive patients for identified period of time. The numbers of patients will be dependent on the volume of each institution and should reflect the local practice.

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.

Eligibility criteria: HCM-Labeled Case Inclusion Criteria:

* Patients with maximum left ventricular wall thickness exceeding 15 mm (including the right ventricular component of the septum) without any other explanation for ventricular hypertrophy (e.g., severe hypertension, cardiac amyloidosis, severe AS, as determined by local investigators). The measurement could be made in an ECHO or on magnetic resonance imaging (MRI).
* Patients must have \> one (1) ECG and/or \> one (1) ECHO available that meet minimum compatibility requirements. If multiple ECGs and ECHOs are available per patient, then all available data meeting compatibility requirements will be used for model training purposes.

HCM-Labeled Case Exclusion Criteria:

* Any sign of infiltration found in cardiac MRI, if performed.

Control Case (Non-HCM) Inclusion Criteria:

* No diagnosis of HCM
* Age/sex are matched to HCM cases (+/- 5 years, if possible; +/- 10 years if numbers do not permit).
* Patient must have \> one (1) ECG and/or \> one (1) ECHO available that meet minimum compatibility requirements. If multiple ECGs and ECHOs are available per patient, then all available data meeting compatibility requirements will be used for model training purposes.

Control Case (Non-HCM) Exclusion Criteria

* Suggestion of HCM in a clinically obtained ECHO or cardiac MRI report unless subsequently confirmed no diagnosis of HCM. Any new clinical information discovered during the study will be left to the discretion of the local investigator.

Primary outcomes:
measure: Diagnosis of HCM
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Diagnosis of different types of HCM
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Kankakee
country: United States
facility: Riverside Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Wooster
country: United States
facility: Wooster Community Hospital
state: Ohio
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: American Heart Association
name: Samantha Johnson, MPH
role: STUDY_DIRECTOR
References: