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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT05108168
Eligibility Criteria:
Inclusion/exclusion criteria
1. Selection criteria for screening (1) 18 years old or older (2) Patients with infiltrative cardiomyopathy (the diagnostic name for each of the following diseases) or systemic disease (such as amyloidosis, multiple myeloma, sarcoidosis) (3) Search Period: January 1, 2010-December 31, 2020
2. Criteria for enrolling patients
* Patients who are satisfied with at least one of each definition are selected.
* Cardiac amyloidosis1,5,11,12 I. 'Definite': Positive myocardial biopsy (Congo-Red positive) II. 'Probable': One of the following imaging findings along with a positive biopsy of tissues other than myocardium A. Positive DPD / PYP scan Grade 2-3 cardiac uptake B. Echocardiography Symmetrical increase in LV and RV wall thickness Dilated LA and RA Granular appearance of myocardium Pericardial effusion Decreased or normal RQS complex voltage despite increased LV wall thickness C. Cardiac magnetic resonance imaging Diffuse subendocardial late Gd-enhancement Elevated native T1 and ECV value III. 'Possible': Two or more of the above imaging findings are satisfied without biopsy findings, and it is suitable for the diagnosis according to all clinical findings
② Cardiac sarcoidosis13,14,15,16 I. 'Definite': If all of the following are satisfied A. Noncaseating, multinucleated giant cell granuloma surrounded by bands of dense collagen fibers in endomyocardial biopsy B. Compatible clinical presentation C. Exclusion of other causes of granulomatous inflammation II. 'Probable': Two or more of the following findings along with a positive biopsy of tissues other than myocardium A. Electrocardiogram High-grade atrioventricular block (including complete atrioventricular block) or fatal ventricular arrhythmia (e.g., sustained ventricular tachycardia and ventricular fibrillation) B. Echocardiography Variable focal LV wall thinning (frequently at the basal septum, lateral wall) Focal wall motion abnormalities do not match coronary artery territory C. Cardiac magnetic resonance imaging Patch, basal and lateral LV wall late Gd-enhancement D. Positron Emission Tomography - Computed Tomography Focal increased FDG-uptake IV. 'Possible': Two or more of the above imaging findings are satisfied without biopsy findings, and it is suitable for the diagnosis according to all clinical findings
* Hemochromatosis 17 I. 'Definite': Positive myocardial biopsy Iron deposits within the myocyte II. 'Probable': Non-myocardial tissue biopsy positive or iron overload clinical evidence (such as hereditary hemochromatosis, transfusion-dependent anemia) and the following imaging findings A. Echocardiography Dilated LV with global systolic dysfunction B. Cardiac magnetic resonance imaging Low T2\* value of myocardium
Etc
① Fabry disease18,19 I. 'Definite': Positive myocardial biopsy Enlarged myocytes with clusters of concentric glycolipid (myelinoid bodies) within lysosomes II. 'Probable': A-galactosidase A screening test and X-linked genetic test positive, along with the following echocardiographic findings A. Echocardiography Symmetrical increase in LV and RV wall thickness
② Danon disease20 I. 'Definite': Positive for genetic testing or biopsy of myocardial tissue, along with the following echocardiographic findings Symmetrical increase in LV and/or RV wall thickness Decreased LV systolic function
③ Cardiac oxalosis1 I. 'Definite': Positive myocardial biopsy II. 'Probable': The following echocardiographic findings along with a history of massive transfusion or positive biopsy of tissues other than myocardium Symmetrical increase in LV and RV wall thickness Patchy, echodense speckled reflection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05108168
Study Brief:
Protocol Section:
NCT05108168