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NCT04083118: AoRTAS
Assessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride
trial testing clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI in Bicuspid Aortic Valve in 95 participants. Completed in 3 September 2023.
3 September 2023
Quick facts
| Lead sponsor | University of Edinburgh |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 95 |
| Start date | 1 April 2019 |
| Primary completion | 3 September 2023 |
| Estimated completion | 3 September 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI
- Repeat 18F sodium fluoride PET/MRI
Conditions studied
- Bicuspid Aortic Valve — all drugs for Bicuspid Aortic Valve →
- Thoracic Aortic Aneurysm — all drugs for Thoracic Aortic Aneurysm →
- Aortic Dissection — all drugs for Aortic Dissection →
Sponsor
University of Edinburgh
Who can join
Adults 20 to 100, any sex, with Bicuspid Aortic Valve or Thoracic Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Microcalcification and Thoracic Aortopathy: A Window Into Disease Severity.
Fletcher AJ, Nash J, Syed MBJ, Macaskill MG, et al · · 2022 · cited 14× · PMID 35770666 · DOI 10.1161/atvbaha.122.317111 -
Molecular Calcification Imaging and Ascending Aortic Disease in Patients With a Bicuspid Aortic Valve.
Nash J, Debono S, Loganath K, Whittington B, et al · · 2026 · PMID 41729522 · DOI 10.1001/jamanetworkopen.2025.60385 -
Thoracic aortic microcalcification activity in combined positron emission tomography and magnetic resonance imaging.
Nash J, Debono S, Whittington B, Kaczynski J, et al · · 2024 · PMID 38456972 · DOI 10.1007/s00259-024-06670-5
Verify or expand the search:
- PubMed search for NCT04083118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bicuspid Aortic Valve
Currently open trials in the same condition.
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- NCT05739253 — Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement · recruiting
- NCT03836521 — Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry · recruiting
- NCT03440697 — Pathogenetic Basis of Aortopathy and Aortic Valve Disease · active not recruiting
Other University of Edinburgh trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04083118 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Edinburgh
- Last refreshed: 29 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04083118.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing