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NCT07819344
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
Conditions: AORTIC VALVE DISEASES, Calcification; Heart
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Massachusetts General Hospital
Summary
This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification. To do so, baseline 18FNaF PET/CT will be obtained to measure AS disease activity and the rate of active microcalcification. Using these data, multi-omics prediction models and calculator tools will be developed to provide an index of ongoing disease activity (active calcification). Follow-up imaging (both echo and CT) will be performed one year after baseline imaging to assess progression. We will test the hypothesis that baseline disease activity (as reported by the predictor models and calculators) is associated with the rate of annualized AS progression in two cohorts (the same cohort using subsequent imaging, as well as the Population Study's cohorts).
Eligibility Criteria
Inclusion Criteria:
* Males and females
* aged 18 years or older
* mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)
Exclusion Criteria:
* Bicuspid Aortic Stenosis
* pregnancy
* cognitive disabilities that impair the ability to comply with instructions or provide informed consent
* any other medical condition that may undermine participation
* weight \>300 lbs
* severe claustrophobia
* Pregnancy
* subjects who have had significant radiation exposure as part of research (\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12 months
* Individuals with renal dysfunction (eGFR\
Source: ClinicalTrials.gov (NCT07819344). StuddyBuddy aggregates publicly available trial information.