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

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ClinicalTrials.gov Identifier: NCT03956394
Recruitment Status : Not yet recruiting
First Posted : May 20, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society

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.


Condition or disease Intervention/treatment Phase
Takayasu Arteritis Diagnostic Test: UltraFast ultrasound Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Evaluation of 10 patients with active Takayasu disease, and 10 with non-active Takayasu disease.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Quantification of the vascularity [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Evaluate average local elasticity of the ultrafast imaging results regarding the disease activity [ Time Frame: Day 1 ]
    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

  2. Evaluate the carotid pulse wave velocity of the ultrafast imaging results regarding the disease activity [ Time Frame: Day 1 ]
    Comparison of the carotid pulse wave velocity according to the Kerr score with ultrafast imaging results

  3. Evaluate the intima-media thickness of common carotid arteries of the ultrafast imaging results regarding the disease activity [ Time Frame: Day 1 ]
    Comparison of intima-media thickness of common carotid arteries (automated software) according to the Kerr score with ultrafast imaging results

  4. Dosage of C-reactive protein [ Time Frame: Day 1 ]
    Evaluate relation between C-reactive protein quantity and the ultrafast imaging results

  5. Calculation of clinical index of disease activity: Indian Takayasu Activity score 2010 (Score <2: inactive disease activity / Score ≥2 active disease activity) [ Time Frame: Day 1 ]
    Evaluate relation between Indian Takayasu Activity score 2010 and the ultrafast imaging results



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956394


Contacts
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Contact: Emmanuel MESSAS, MD +331.56.09.37.55 emmanuel.messas@aphp.fr
Contact: Tessa BERGOT +33144907033 tessa.bergot@sfcardio.fr

Locations
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France
Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France, 75012
Contact: Emmanuel MESSAS, MD    +331.56.09.37.55    emmanuel.messas@aphp.fr   
Contact: Guillaume GOUDOT, MD    +331.56.09.37 55    guillaume.goudot@aphp.fr   
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Emmanuel MESSAS, MD Hôpital Européen Georges-Pompidou

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT03956394     History of Changes
Other Study ID Numbers: 2017-02
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by French Cardiology Society:
Cardiovascular Diseases
Vascular Diseases

Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases