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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05619302
Eligibility Criteria:
Inclusion Criteria for AL-amyloid subjects:
* Age \> 18 years
* Willing and able to provide consent
* AL-CA: Diagnosis of systemic light chain amyloidosis by standard criteria: Immunofixation of serum, serum free light chain (FLC) assay, a biopsy of fat pad/bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed AND
* Proof of cardiac involvement by AL amyloidosis
* Abnormal cardiac biomarkers: abnormal high sensitivity TnT 5th generation levels (\> 15 ng/L) or abnormal age-appropriate NT-proBNP (abnormal values: \< 50 years: \> 450 pg/ml; 50-75 years: \> 900 pg/ml; \> 75 years: \> 1800 pg/ml) OR
* Abnormal echocardiogram (wall thickness \> 12 mm in the absence of other causes of increased LV wall thickness) OR
* Abnormal CMR (wall thickness \> 12 mm, extracellular volume \> 0.40 or typical CMR appearance of cardiac amyloidosis with difficulty nulling images and non-coronary distribution late gadolinium enhancement) OR
* Positive endomyocardial biopsy
Inclusion Criteria for ATTR-amyloid subjects:
* Age \> 18 years
* Willing and able to provide consent
* ATTR-CA: Diagnosis of either wildtype or hereditary transthyretin cardiac amyloidosis by standard criteria: Endomyocardial biopsy followed by typing of the transthyretin amyloidosis using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed
* Extracardiac biopsy with typical cardiac imaging findings
* Hereditary ATTR amyloidosis by genetic testing OR
* Grade 2 or grade 3 myocardial uptake of 99mTc-PYP if AL amyloidosis is excluded
Inclusion Criteria for recent myocardial infarction subjects:
* Age \> 18 years
* Willing and able to provide consent
* Recent MI: Diagnosis of recent type 1 myocardial infarction by standard criteria
* More than 6 weeks from diagnosis of MI but within 6 months
* Imaging evidence of loss of viable myocardium or persistent regional wall motion abnormalities in a pattern consistent with an ischemic etiology in more than one segment
Inclusion Criteria for hypertrophic cardiomyopathy subjects:
* Age \> 18 years
* Willing and able to provide consent
* Hypertrophic cardiomyopathy: Diagnosis of hypertrophic cardiomyopathy by standard criteria
* MRI evidence of late gadolinium enhancement
Inclusion Criteria for recent healthy control subjects:
* Age \> 18 years
* Willing and able to provide consent
* No known cardiac amyloidosis or recent myocardial infarction
Exclusion Criteria:
* Dialysis
* NYHA (New York Heart Association) Class IV
* Acute myocardial infarction within 6 weeks
* Pregnancy or nursing
* History of adverse events from or allergy to gadolinium contrast media
* Hemodynamic instability
* Severe claustrophobia despite use of sedatives
* Decompensated heart failure (unable to lie flat for 1 hour)
* Concomitant clinically significant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
* Body weight over limit for MRI table (\>300 lbs)
* Contraindications for MRI (including non-compatible cardiac implantable electronic devices, drug infusion pumps, and metallic or electric implants)
* Any other reason determined by the investigator to be unsuitable for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05619302
Study Brief:
Protocol Section:
NCT05619302