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Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 5 words Study description shortened, about 5 words Show 1 more changeShow less
    • Study description shortened, about 5 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07819344
Lead Sponsor Massachusetts General Hospital
Conditions AORTIC VALVE DISEASES, Calcification; Heart
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov