Brief Title
18F-NaF Uptake and Aortic Stenosis Progression
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
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 Type
Observational
Primary Outcome
mean PG
Condition
Aortic Stenosis
Intervention
Imaging test: 18F-NaF PET/CT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
28
Start Date
May 2016
Completion Date
November 2017
Primary Completion Date
August 2017
Eligibility Criteria
Inclusion Criteria: - over 20 years old - moderate aortic stenosis Exclusion Criteria: - age < 20 yrs - pregnant women
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ho-Joong Youn, MD, 82-2-2258-1128, [email protected]
Administrative Informations
NCT ID
NCT02740088
Organization ID
NAFAS
Responsible Party
Principal Investigator
Study Sponsor
Seoul St. Mary's Hospital
Study Sponsor
Ho-Joong Youn, MD, Principal Investigator, Seoul St. Mary's Hospital
Verification Date
April 2016