Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Detection of Hypertrophic Cardiomyopathy Using Electrocardiograms and Echocardiograms Through Federated Learning
Overview
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.
Primary outcome measures
- Diagnosis of HCM [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (1)
- Diagnosis of different types of HCM [Time frame: Through study completion, an average of 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 6 centers
- Thomas Hospital — Fairhope
- Riverside Medical Center — Kankakee
- Johns Hopkins University School of Medicine — Baltimore
- University of Michigan Medical Center — Ann Arbor
- Wooster Community Hospital — Wooster
- The University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06461468 · HCM FLIP