Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging (TAK-UF)
Primary Purpose
Takayasu Arteritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
UltraFast ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Takayasu Arteritis focused on measuring Cardiovascular Diseases, Vascular Diseases
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
Sites / Locations
- Hôpital Européen Georges Pompidou
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Active Takayasu disease
Non-active Takayasu disease
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Dosage of C-reactive protein
Evaluate relation between C-reactive protein quantity and the ultrafast imaging results
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
Full Information
NCT ID
NCT03956394
First Posted
May 16, 2019
Last Updated
March 22, 2022
Sponsor
French Cardiology Society
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03956394
Brief Title
Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging
Acronym
TAK-UF
Official Title
Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu Arteritis
Keywords
Cardiovascular Diseases, Vascular Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Evaluation of 10 patients with active Takayasu disease, and 10 with non-active Takayasu disease.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Takayasu disease
Arm Type
Other
Arm 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.
Arm Title
Non-active Takayasu disease
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
UltraFast ultrasound
Intervention Description
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 Measure Information:
Title
Quantification of the vascularity
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Evaluate average local elasticity of the ultrafast imaging results regarding the disease activity
Description
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
Time Frame
Day 1
Title
Evaluate the carotid pulse wave velocity of the ultrafast imaging results regarding the disease activity
Description
Comparison of the carotid pulse wave velocity according to the Kerr score with ultrafast imaging results
Time Frame
Day 1
Title
Evaluate the intima-media thickness of common carotid arteries of the ultrafast imaging results regarding the disease activity
Description
Comparison of intima-media thickness of common carotid arteries (automated software) according to the Kerr score with ultrafast imaging results
Time Frame
Day 1
Title
Dosage of C-reactive protein
Description
Evaluate relation between C-reactive protein quantity and the ultrafast imaging results
Time Frame
Day 1
Title
Calculation of clinical index of disease activity: Indian Takayasu Activity score 2010 (Score <2: inactive disease activity / Score ≥2 active disease activity)
Description
Evaluate relation between Indian Takayasu Activity score 2010 and the ultrafast imaging results
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel MESSAS, MD
Organizational Affiliation
Hôpital Européen Georges-Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
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Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging
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