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Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956394
Acronym
TAK-UF
Enrollment
16
Registered
2019-05-20
Start date
2020-01-08
Completion date
2021-12-31
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takayasu Arteritis

Keywords

Cardiovascular Diseases, Vascular Diseases

Brief summary

The general activity of Takayasu vasculitis is correlated with the perfusion rate of the carotid arterial wall. This can be quantified with ultrafast ultrasound imaging in sensitive Doppler sequence associated with the concomitant injection of microbubbles (SonoVue®). The hypothesis is that the carotid artery wall flow parameters obtained with ultrafast ultrasound imaging make possible to discriminate an active disease from an inactive disease because of the fibrous sequential arterial thickening. Thus, to improve the evaluation of Takayasu vasculitis activity and to refine the criteria for response to the various immunomodulatory treatments used.

Detailed description

Takayasu vasculitis is a systemic inflammatory disease that causes progressive thickening and stenosis of large and medium-sized arteries (the aorta and its branches, as well as the pulmonary arteries). The classic histological aspect corresponds to a chronic inflammation localized to the arterial wall. Vascular imaging plays an important role in the diagnosis and monitoring of these patients. Although Doppler ultrasound, MRI and computed tomography can simply assess recognized inflammation criteria, such as thickening or signal intensity of the arterial wall, to recognize Takayasu vasculitis in the early stages of inflammation of the disease, there is no clear correlation between the presence of these signs and the activity or progression of the disease. However, assessment of Takayasu vasculitis activity is difficult in daily practice because symptoms, physical examination, and biological parameters may not reliably reflect vascular inflammation. Finally, unlike other small- and medium-vessel vasculitis, histology is rarely available to diagnose and evaluate the activity of patients with Takayasu vasculitis. In order to identify local markers of disease activity, contrast ultrasound (with injection of SonoVue® microbubbles) has shown its ability to visualize the presence of micro-vessels within the carotid wall. Ultrafast Ultrasound Imaging provides a more accurate exploration of the small vasorum vessels compared to contrast ultrasound. This technology has already been the subject of a study on cerebral microvasculature. In its application on the carotid wall, it will allow easier quantification than conventional ultrasound, by a signal analysis in ultrafast Doppler and not on the gray level, much more variable.

Interventions

DIAGNOSTIC_TESTUltraFast ultrasound

The patient will be hospitalized by day to perform the usual follow-up of the Takayasu disease: blood sampling and Doppler ultrasound control. Then UltraFast ultrasound doppler will be assessed.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
French Cardiology Society
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Evaluation of 10 patients with active Takayasu disease, and 10 with non-active Takayasu disease.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Takayasu disease diagnosed according to the American College of Rheumatology 1990 criteria

Exclusion criteria

* Carotid damaged not related to Takayasu disease: atherosclerosis, post-radiation stenosis. * Contraindication with the use of SonoVue®: * Unstable ischemic heart disease (recent myocardial infarction, resting angina within 7 days) * Acute heart failure * Stage III or IV heart failure * Severe rhythm disorders * Patients with right-left shunt * Severe pulmonary arterial hypertension (pulmonary arterial pressure\> 90 mmHg) * Uncontrolled systemic hypertension * Patients with respiratory distress syndrome * Severe chronic obstructive pulmonary disease. * Acute endocarditis * Heart valve prostheses * Sepsis * Hypercoagulation and / or recent thromboembolic events * Terminal stage of kidney or liver disease. * Hypersensitivity to sulfur hexafluoride or any of the other ingredients of SonoVue® * Pregnancy or breastfeeding. * Participation in another biomedical research protocol. * Refusal or incapacitation of language or psychic to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
Quantification of the vascularityDay 1Quantification of the parietal vascularization in sensitive Doppler on the common carotid artery after injection of Sonovue® contrast product: quantification of the absolute signal, relative to the carotid wall surface evaluated.

Secondary

MeasureTime frameDescription
Evaluate average local elasticity of the ultrafast imaging results regarding the disease activityDay 1Comparison of average local elasticity by shear wave elastography (anterior and posterior walls of common carotid arteries) according to the Kerr score with ultrafast imaging results
Evaluate the carotid pulse wave velocity of the ultrafast imaging results regarding the disease activityDay 1Comparison of the carotid pulse wave velocity according to the Kerr score with ultrafast imaging results
Evaluate the intima-media thickness of common carotid arteries of the ultrafast imaging results regarding the disease activityDay 1Comparison of intima-media thickness of common carotid arteries (automated software) according to the Kerr score with ultrafast imaging results
Dosage of C-reactive proteinDay 1Evaluate relation between C-reactive protein quantity and the ultrafast imaging results
Calculation of clinical index of disease activity: Indian Takayasu Activity score 2010 (Score <2: inactive disease activity / Score ≥2 active disease activity)Day 1Evaluate relation between Indian Takayasu Activity score 2010 and the ultrafast imaging results

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026