Hypertrophic Cardiomyopathy Federated Learning Implementation Platform

NCT06461468 | Enrolling By Invitation

• 1 other identifier: HCM FLIP
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief Summary

HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.

Conditions

Hypertrophic Cardiomyopathy

Keywords

HCM; Hypertrophic Cardiomyopathy; Federated Learning; Federated Learning Platform; FLP

Outcome Measures

Primary Outcomes (1)

• Diagnosis of HCM

  The number/instances of HCM diagnoses as identified by the ML model as compared to clinical diagnosis confirmation. Due to model training and efficacy goals, HCM diagnosis determined clinically via EKG/ECHO reading will be compared to the ML model's capacity to identify HCM correctly and efficiently.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• Diagnosis of different types of HCM

  Through study completion, an average of 2 years

Study Arms (2)

HCM-Labeled Cases

Cases 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 aortic stenosis (AS)). The measurement could be made in an echocardiogram or on magnetic resonance imaging (MRI).

Control Cases (Non-HCM)

No diagnosis of HCM.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• American Heart Association: lead

Study Sites (6)

Thomas Hospital

Fairhope, Alabama, 36532, United States

Location

Riverside Medical Center

Kankakee, Illinois, 60901, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Wooster Community Hospital

Wooster, Ohio, 44691, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Samantha Johnson, MPH

  American Heart Association

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 17, 2024
• Study Start: June 5, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)