Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity

NCT07819344 | Not Yet Recruiting

• 2 other identifiers: 2026p00110026SFRNPVHD1623048
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

AORTIC VALVE DISEASES; Calcification; Heart

Keywords

aortic stenosis; calcification; positron emission tomography; calculator

Outcome Measures

Primary Outcomes (1)

• rate of AS progression

  change of echo- and CT-derived AS measures

  One year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 subjects with mild or moderate aortic stenosis

You may qualify if:

• Males and females
• aged 18 years or older
• mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (1)

• Otto CM, Newby DE, Hillis GS. Calcific Aortic Stenosis: A Review. JAMA. 2024 Dec 17;332(23):2014-2026. doi: 10.1001/jama.2024.16477.

  PMID: 39527048 BACKGROUND

Related Links

• Link to MGB IRB

MeSH Terms

Conditions

Aortic Valve Disease; Calcinosis; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Ahmed Tawakol A Director, MD

CONTACT

6177262000; atawakol@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Cardiovscular Imaging Research Center

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 30, 2031
• Last Updated: September 16, 2026

Record last verified: 2026-09