18F-NaF Uptake and Aortic Stenosis Progression

• Conditions: Aortic Stenosis

• Registration Number: NCT02740088
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Study Timeline

• Status Verified: 2016-04
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Study Start: 2016-05
• Primary Completion: 2017-08
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• over 20 years old
• moderate aortic stenosis

Exclusion Criteria

• age < 20 yrs
• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean PG	AS severity progression after 1 year