Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging

NCT03956394 | Completed

• 1 other identifier: 2017-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Takayasu Arteritis

Keywords

Cardiovascular Diseases; Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Day 1

• Evaluate the carotid pulse wave velocity of the ultrafast imaging results regarding the disease activity

  Day 1

• Evaluate the intima-media thickness of common carotid arteries of the ultrafast imaging results regarding the disease activity

  Day 1

• Dosage of C-reactive protein

  Day 1

• Calculation of clinical index of disease activity: Indian Takayasu Activity score 2010 (Score <2: inactive disease activity / Score ≥2 active disease activity)

  Day 1

Study Arms (2)

Active Takayasu disease

OTHER

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

Non-active Takayasu disease

OTHER

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

Interventions

UltraFast ultrasound 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.

Active Takayasu disease; Non-active Takayasu disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75012, France

Location

Related Publications (1)

• 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.

  PMID: 38488572 DERIVED

MeSH Terms

Conditions

Takayasu Arteritis; Cardiovascular Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emmanuel MESSAS, MD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: January 8, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

FR (1)