Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

NCT ID: NCT03956394

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2021-12-31

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.

Conditions

Takayasu Arteritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

UltraFast ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: OTHER

UltraFast ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel MESSAS, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges-Pompidou

Locations

Hôpital Européen Georges Pompidou

Paris, , France

Countries

France

References

Goudot G, Jimenez A, Mohamedi N, Sitruk J, Wang LZ, Khider L, Bruneval P, Messas E, Pernot M, Mirault T. Vasa vasorum interna in the carotid wall of active forms of Takayasu arteritis evidenced by ultrasound localization microscopy. Vasc Med. 2024 Jun;29(3):296-301. doi: 10.1177/1358863X241228262. Epub 2024 Mar 15.

Reference Type: DERIVED

PMID: 38488572 (View on PubMed)

Other Identifiers

2017-02

Identifier Type: -

Identifier Source: org_study_id