Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Males and females

aged 18 years or older

mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)

Disqualifiers

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

Trial population

100 subjects with mild or moderate aortic stenosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Individuals with mild or moderate aortic stenosis

Trial outcomes

Primary outcomes

1

rate of AS progression

change of echo- and CT-derived AS measures

Time frame
One year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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