18F-NaF Uptake and Aortic Stenosis Progression

NCT ID: NCT02740088

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Imaging test: 18F-NaF PET/CT

18F-NaF PET/CT as an imaging test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* over 20 years old
* moderate aortic stenosis

Exclusion Criteria

* age \< 20 yrs
* pregnant women
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ho-Joong Youn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ho-Joong Youn, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Central Contacts

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Ho-Joong Youn, MD

Role: CONTACT

82-2-2258-1128

Other Identifiers

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NAFAS

Identifier Type: -

Identifier Source: org_study_id

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