Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging (TAK-UF)

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.

Study Overview

• Status: Completed
• Conditions: Takayasu Arteritis
• Intervention / Treatment: Diagnostic test: UltraFast ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hôpital Européen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active Takayasu disease; UltraFast ultrasound will be performed in the usual health care, with the evaluation of carotid artery disease by Doppler ultrasound in patients hospitalized for Takayasu Arteritis Assessment.	Diagnostic test: UltraFast 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.
Other: Non-active Takayasu disease; UltraFast ultrasound will be performed in the usual health care, with the evaluation of carotid artery disease by Doppler ultrasound in patients hospitalized for Takayasu Arteritis Assessment.	Diagnostic test: UltraFast 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of the vascularity	Quantification 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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate average local elasticity of the ultrafast imaging results regarding the disease activity	Comparison 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	Day 1
Evaluate the carotid pulse wave velocity of the ultrafast imaging results regarding the disease activity	Comparison of the carotid pulse wave velocity according to the Kerr score with ultrafast imaging results	Day 1
Evaluate the intima-media thickness of common carotid arteries of the ultrafast imaging results regarding the disease activity	Comparison of intima-media thickness of common carotid arteries (automated software) according to the Kerr score with ultrafast imaging results	Day 1
Dosage of C-reactive protein	Evaluate relation between C-reactive protein quantity and the ultrafast imaging results	Day 1
Calculation of clinical index of disease activity: Indian Takayasu Activity score 2010 (Score <2: inactive disease activity / Score ≥2 active disease activity)	Evaluate relation between Indian Takayasu Activity score 2010 and the ultrafast imaging results	Day 1

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes
• Other Study ID Numbers: 2017-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No