Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT06461468
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06461468
Study Brief:
Protocol Section:
NCT06461468