NCT06461468
Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
Enrolling by Invitation
Not specifiedAges 18+ObservationalAmerican Heart AssociationInvestigator-initiated
~1,000 participants
Updated 2024-08-06 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnosis of HCM
Measured over Through study completion, an average of 2 years
Conditions
Where it's being run
6 sites across 6 statesAlabama1
Illinois1
Maryland1
Michigan1
Ohio1
Texas1
Study leadership
- Samantha Johnson, MPH · STUDY_DIRECTOR · American Heart Association
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Exclusion
Any sign of infiltration found in cardiac MRI, if performed.
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.
What this trial measures
- Diagnosis of HCMThrough study completion, an average of 2 years
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.