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

NCT04083118 | Completed

• 2 other identifiers: 2018/0261FS/19/15/34155
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

positron emission tomography; sodium fluoride; bicuspid aortic valve; thoracic aortic aneurysm; aortopathy

Outcome Measures

Primary Outcomes (1)

• Aortic growth rate

  Correlate baseline 18F sodium fluoride PET uptake with aortic growth rate, a marker of aortic wall remodelling, over 1-2 years

  At 1-2 years after baseline visit

Secondary Outcomes (2)

• Aortic stiffness

  1-2 years (at second study visit)

• Wall shear stress

  1 year (at baseline visit)

Study Arms (2)

Bicuspid aortic valve

80 patients with bicuspid aortic valve with or without an aortic aneurysm

Diagnostic Test: clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI; Diagnostic Test: Repeat 18F sodium fluoride PET/MRI

controls

20 healthy volunteer controls age and sex matched to 20 of the bicuspid aortic valve patients

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

Interventions

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

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

Bicuspid aortic valve; controls

Repeat 18F sodium fluoride PET/MRI DIAGNOSTIC_TEST

as per first study visit but without the PET/CT

Bicuspid aortic valve

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bicuspid aortic valve and a variety of ascending aortic sizes

You may qualify if:

• Bicuspid aortic Valve or Age-sex matched healthy volunteer

You may not qualify if:

• Pregnancy
• eGFR \< 30
• previous aortic replacement surgery
• previous aortic valve surgery
• contrast allergy
• other reason unable to undergo MRI

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Related Publications (2)

• Fletcher AJ, Nash J, Syed MBJ, Macaskill MG, Tavares AAS, Walker N, Salcudean H, Leipsic JA, Lim KHH, Madine J, Wallace W, Field M, Newby DE, Bouchareb R, Seidman MA, Akhtar R, Sellers SL. Microcalcification and Thoracic Aortopathy: A Window Into Disease Severity. Arterioscler Thromb Vasc Biol. 2022 Aug;42(8):1048-1059. doi: 10.1161/ATVBAHA.122.317111. Epub 2022 Jun 30.

  PMID: 35770666 BACKGROUND

• Fletcher AJ, Lembo M, Kwiecinski J, Syed MBJ, Nash J, Tzolos E, Bing R, Cadet S, MacNaught G, van Beek EJR, Moss AJ, Doris MK, Walker NL, Dey D, Adamson PD, Newby DE, Slomka PJ, Dweck MR. Quantifying microcalcification activity in the thoracic aorta. J Nucl Cardiol. 2022 Jun;29(3):1372-1385. doi: 10.1007/s12350-020-02458-w. Epub 2021 Jan 20.

  PMID: 33474695 BACKGROUND

Related Links

• BHF website
• University of Edinburgh website

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples taken at each visit with ethical approval and consent to store for DNA

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease; Aortic Aneurysm, Thoracic; Aortic Dissection

Interventions

Physical Examination; Pulse Wave Analysis

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Alexander J Fletcher, MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 10, 2019
• Study Start: April 1, 2019
• Primary Completion: September 3, 2023
• Study Completion: September 3, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

GB (1)