18F-NaF Uptake and Aortic Stenosis Progression

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02740088
• Other study ID #: NAFAS
• Status: Not yet recruiting
• Phase: N/A
• First received: April 11, 2016
• Last updated: April 11, 2016
• Start date: May 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2016
• Source: Seoul St. Mary's Hospital
• Contact: Ho-Joong Youn, MD
• Phone: 82-2-2258-1128
• Email: younhj[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• over 20 years old

• moderate aortic stenosis

Exclusion Criteria:

• age < 20 yrs

• pregnant women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• Imaging test: 18F-NaF PET/CT
18F-NaF PET/CT as an imaging test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean PG		AS severity progression after 1 year	No