New ultrasound score may better monitor rare artery disease
NCT ID NCT07571577
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test whether a special ultrasound score, called OTUS, can accurately track disease activity in people with Takayasu arteritis, a rare condition that causes inflammation of the large arteries. Researchers will follow 100 patients with active disease, performing ultrasound scans during routine check-ups to see if the score changes as the disease improves or worsens. The goal is to find a better way to monitor the disease without relying solely on blood tests or doctor judgment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide a reliable, non-invasive tool to monitor disease activity and guide treatment decisions for Takayasu arteritis.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly improve outcomes. The score may not prove sensitive enough to replace current monitoring methods.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of patients with TAK and active disease, either newly diagnosed or experiencing a relapse. Active disease is defined as the presence of clinical signs and/or symptoms attributable to TAK, with or without elevation of inflammatory markers (ESR, CRP), and/or imaging evidence of active vasculitis (excluding US findings used in OTUS scoring). Patients of any gender, aged ≥18 years, will be eligible.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Male and female * Diagnosis of TAK according to the 1990 ACR and/or 2022 ACR/EULAR classification criteria * Active disease, defined as the presence of at least two of the following three domains: * Clinical domain: new onset or worsening of clinical signs and/or symptoms attributable to TAK; * Laboratory domain: elevation of inflammatory markers, defined as ESR and/or CRP above the upper limit of normal according to local laboratory standards, not attributable to causes other than TAK; * Imaging domain: imaging evidence of active vasculitis on modalities other than ultrasound, including FDG-PET, magnetic resonance angiography (MRA), or computed tomography angiography (CTA). * Ability to undergo serial vascular ultrasound assessments during follow-up * Provision of signed informed consent Exclusion Criteria: * Inability or contraindication to undergo vascular US * Severe comorbidities limiting participation or follow-up * Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation) * Diagnosis of another rheumatologic disease * Refusal or inability to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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