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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT07232459
Eligibility Criteria:
1. Subject Recruitment Participants will be recruited from outpatients and/or inpatient populations of the Hematology Department at Tianjin Medical University General Hospital. The principal investigator and collaborating hematologists will ensure consistent application of diagnosis and enrollment criteria based on standardized guidelines. The planned enrollment includes 20 patients with systemic amyloidosis (including cardiac involvement) and 5 healthy volunteers.
2. Amyloidosis Patients:
2.1 Inclusion Criteria:
Subjects must meet all of the following criteria:
1. Adult patients (age ≥ 18 years);
2. Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis.
3. Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation.
4. Able to understand the study procedures and provide written informed consent. 2.2 Exclusion Criteria
Subjects will be excluded based on any of the following:
1. Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.
2. Pregnancy or breastfeeding.
3. Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up.
3\. Healthy Volunteers: 3.1 Inclusion Criteria:
Subjects must meet all of the following criteria:
1. Adult subjects (age ≥ 18 years);
2. No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).
3. Able to understand the study procedures and provide written informed consent. 3.2 Exclusion Criteria:
Subjects will be excluded based on any of the following:
1. History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder.
2. Pregnancy or breastfeeding.
3. Any condition that, in the opinion of the investigator, could pose an increased risk from the study procedure or interfere with the interpretation of study data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07232459
Study Brief:
Protocol Section:
NCT07232459