NCT02740088

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

April 11, 2016

Last Update Submit

April 11, 2016

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • mean PG

    AS severity progression after 1 year

Interventions

Imaging test: 18F-NaF PET/CTOTHER

18F-NaF PET/CT as an imaging test

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diagnosed as "moderate aortic stenosis" by echocardiography

You may qualify if:

  • over 20 years old
  • moderate aortic stenosis

You may not qualify if:

  • age \< 20 yrs
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Ho-Joong Youn, MD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Joong Youn, MD

CONTACT

82-2-2258-1128younhj@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 15, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

April 15, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share