18F-NaF Uptake and Aortic Stenosis Progression

April 11, 2016 updated by: Ho-Joong Youn, Seoul St. Mary's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diagnosed as "moderate aortic stenosis" by echocardiography

Description

Inclusion Criteria:

  • over 20 years old
  • moderate aortic stenosis

Exclusion Criteria:

  • age < 20 yrs
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean PG
Time Frame: AS severity progression after 1 year
AS severity progression after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Principal Investigator: Ho-Joong Youn, MD, Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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