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Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
Molecular Imaging and Deep Phenotyping to Identify Predictors of AS Disease Activity and Progression
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Structural imaging modalities, such as echocardiography (echo) and computed tomography (CT), measure the structural consequences of aortic valvular calcification and have proven invaluable for grading AS severity. However, these techniques cannot capture the dynamic microcalcification processes that drive the underlying disease and have proven insufficient for predicting AS progression. In contrast, molecular imaging with 18F-NaF positron emission tomography/computed tomography (18F-NaF PET/CT) is the gold-standard method for noninvasively measuring the central pathophysiological process driving the progression of AS. This imaging approach uses 18F-sodium fluoride, a tracer that binds preferentially to hydroxyapatite in regions of developing microcalcification. This enables quantification of microcalcification activity (which precedes visible macrocalcification) and provides insights into the underlying disease activity that drives AS progression. Notably, optimized protocols for 18F-NaF PET/CT yield a reproducible biomarker to track disease activity and predict progression. Furthermore, recent advances in PET technology (such as total-body PET scanners) have improved sensitivity by 10- to 40-fold, further enhancing the quantification of the microcalcification rate underlying AS progression.
Overall, the assessment of microcalcification activity shifts the focus from static anatomical assessments to measurement of the dynamic pathological process driving AS progression. However, while 18F-NaF PET/CT is unsuitable for routine clinical use (because it is costly and currently limited to research applications), it can be effectively leveraged to train predictive models and deploy them as clinical calculators to estimate the rate of microcalcification from readily available biomarker data. The resulting clinical models and calculators could greatly enhance clinical care by identifying patients at risk of rapid progression, refining risk stratification and prognostic accuracy, and opening avenues for personalized monitoring and treatment in calcific AS.
The overarching goal of this Clinical Imaging Study is to develop novel predictive models and clinical calculators that capture AS microcalcification activity and forecast the risk of progressive aortic valve stenosis among participants with mild-to-moderate AS. The investigators will achieve this by performing advanced multimodality imaging, including 18F-NaF PET/CT, to quantify microcalcification activity in deeply phenotyped patients using clinical, imaging, and blood plasma biomarkers. Computational approaches, including AI tools, will identify optimal combinations of imaging and non-imaging predictors of microcalcification activity. The investigators will then develop accessible clinical calculators and test the hypothesis that these models and calculators enhance identification of rapid progressors through cross-validation and external validation in the Population Project cohort (which undergoes identical biomarker phenotyping).
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Ahmed Tawakol A Director, MD
- Telefoonnummer: 3699 6177262000
- E-mail: atawakol@mgh.harvard.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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<55) or a history of allergic reaction to iodinated contrast will not receive the iodinated contrast.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Individuals with mild or moderate aortic stenosis
Mild or moderate aortic stenosis noted on imaging and not expected to undergo treatment of the aortic valve over the next year.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
rate of AS progression
Tijdsspanne: One year
|
change of echo- and CT-derived AS measures
|
One year
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026p001100
- 26SFRNPVHD1623048 (Ander subsidie-/financieringsnummer: American Heart Association)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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