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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT04738266
Eligibility Criteria:
Inclusion Criteria:
All the following:
* Interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women;
* Left ventricular ejection fraction ≥ 50%;
* Indexed end-diastolic left ventricular volume ≤ 85 mL/m2.
AND
At least one of the following criteria:
* "Granular sparkling" appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections;
* Pericardial effusion regardless of severity;
* Increased interatrial septum thickness (\> 5 mm);
* Restrictive filling pattern (Dec. Time E wave \<120 ms or Dec. Time E wave ≤150 ms e E/A ratio ≥2) or increased ventricular filling pressures (E/E'15);
* Speckle tracking derived global longitudinal strain with apical sparing pattern;
* Increased thickness (\> 5 mm) of mitral and tricuspid valve leaflets.
Exclusion Criteria:
* Patients aged \< 55 years or \> 100 years
* Echocardiography performed due to known or suspected amyloid cardiomyopathy;
* Echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies;
* Refuse to sign the informed consent to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
100 Years
Study:
NCT04738266
Study Brief:
Protocol Section:
NCT04738266