An observational study in Hypertrophic Cardiomyopathy, sponsored by American Heart Association. Enrolling by invitation at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by American Heart Association · Observational
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.
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.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 259 across 174 observational studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →American Heart Association is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
HCM-Labeled Case Inclusion Criteria:
HCM-Labeled Case Exclusion Criteria:
Control Case (Non-HCM) Inclusion Criteria:
Control Case (Non-HCM) Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
No diagnosis of HCM.
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.
Time frame: Through study completion, an average of 2 years
Diagnosis of different types of HCM
Diagnosis of different types of HCM (i.e., apical, obstructive), HCM without hypertrophy, genetic positive/negative indicators, among others, 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.
Time frame: Through study completion, an average of 2 years
Plan to share: No — No participant data is identifiable nor will be shared across participating institutions.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Cardiomyopathy, Hypertrophic →
American Heart Association