Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

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Brief Title

Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

Official Title

Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

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.
    


Study Type

Interventional


Primary Outcome

Quantification of the vascularity

Secondary Outcome

 Evaluate average local elasticity of the ultrafast imaging results regarding the disease activity

Condition

Takayasu Arteritis

Intervention

UltraFast ultrasound

Study Arms / Comparison Groups

 Active Takayasu disease
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

20

Start Date

January 8, 2020

Completion Date

June 1, 2021

Primary Completion Date

June 1, 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Emmanuel MESSAS, MD, +331.56.09.37.55, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03956394

Organization ID

2017-02


Responsible Party

Sponsor

Study Sponsor

French Cardiology Society

Collaborators

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

Study Sponsor

Emmanuel MESSAS, MD, Principal Investigator, Hôpital Européen Georges-Pompidou


Verification Date

September 2020