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Assessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride

NCT04083118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2023-11-29

No results posted yet for this study

Summary

Patients with bicuspid aortic valve-related aortopathy are at increased risk of aortic dilatation, dissection and rupture. Currently, risk stratification is largely based on aortic diameter measurements, with those deemed high risk referred for aortic replacement surgery. This approach is imperfect, and potentially exposes many patients to unnecessary high-risk aortic surgery, or fails to identify those at risk of dissection or rupture with smaller diameters. In patients with abdominal aortic aneurysms, the investigators recently demonstrated that uptake of 18F-sodium fluoride predicts disease progression and clinical events independent of aneurysm diameter and standard clinical risk factors. Based on the investigators preliminary data, a study was proposed to look at 18F-sodium fluoride uptake in patients with bicuspid aortic valve-related aortopathy. The proposed study will shed light on the underlying pathological processes involved in aortic complications of this disease as well as potentially providing an important risk marker to predict disease progression and guide the need for major aortic surgery.

Conditions

  • Bicuspid Aortic Valve
  • Thoracic Aortic Aneurysm
  • Aortic Dissection

Interventions

DIAGNOSTIC_TEST

clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI

Patients will receive a structured clinic history, examination, blood sampling, pulse wave analysis, pulse wave velocity, 18F-sodium fluoride PET/CT, 18F-sodium fluoride PET/MRI with detailed cardiac magnetic resonance imaging and magnetic resonance imaging of the aorta

DIAGNOSTIC_TEST

Repeat 18F sodium fluoride PET/MRI

as per first study visit but without the PET/CT

Sponsors & Collaborators

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Alexander J Fletcher, MD · University of Edinburgh

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-09-03
Completion
2023-09-03

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083118 on ClinicalTrials.gov