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18F-NaF Uptake and Aortic Stenosis Progression

Clinical Value of 18F-sodium Fluoride Uptake at the Aortic Valve for Prediction of the Progression in Patients With Moderate Aortic Stenosis: a Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02740088
Enrollment
28
Registered
2016-04-15
Start date
2016-05-31
Completion date
2017-11-30
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Brief summary

This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis. Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up echocardiography. The study design is an observational trial. Primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. Secondary endpoints include changes in aortic valve area, and symptom occurrence.

Detailed description

Recent studies demonstrated 18F-sodium fluoride (NaF) uptake activity as a marker of early-stage calcification. Although valve calcification could be visualized either by echocardiography or coronary computed tomography, they only reflect the current burden of calcium deposit not the activity of calcium deposit. Limited studies exist regarding the usefulness of 18F-NaF uptake at aortic valve for prediction of stenosis progression. Patients with moderate aortic stenosis - diagnosed by echocardiography - will be enrolled. Enrolled participants will undergo baseline 18F-NaF PET/CT within 6 weeks of baseline echocardiography and followed up for 1 year. After 1 year, all the participants are required to evaluate the aortic stenosis progression by performing echocardiography. The objective of the study is to test whether baseline 18F-NaF uptake activity predict AS progression.

Interventions

OTHERImaging test: 18F-NaF PET/CT

18F-NaF PET/CT as an imaging test

Sponsors

Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* over 20 years old * moderate aortic stenosis

Exclusion criteria

* age \< 20 yrs * pregnant women

Design outcomes

Primary

MeasureTime frame
mean PGAS severity progression after 1 year

Contacts

Primary ContactHo-Joong Youn, MD
younhj@catholic.ac.kr82-2-2258-1128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026