Aortic Stenosis Clinical Trial
Official title:
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
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.
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.
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