NCT02740088

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
• Phase: —
• Study type: Observational
• Enrollment: 28 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
OTHER	Imaging test: 18F-NaF PET/CT	18F-NaF PET/CT as an imaging test

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-08-01
• Completion: 2017-11-01
• First posted: 2016-04-15
• Last updated: 2016-04-15