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Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging (TAK-UF)
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 |
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 (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 |
| Actual Study Start Date : | January 8, 2020 |
| Estimated Primary Completion Date : | June 1, 2021 |
| Estimated Study Completion Date : | June 1, 2021 |
| 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.
|
- 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.
- 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
- 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
- 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
- Dosage of C-reactive protein [ Time Frame: Day 1 ]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) [ Time Frame: Day 1 ]Evaluate relation between Indian Takayasu Activity score 2010 and the ultrafast imaging results
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Emmanuel MESSAS, MD | +331.56.09.37.55 | emmanuel.messas@aphp.fr | |
| Contact: Tessa BERGOT | +33144907033 | tessa.bergot@sfcardio.fr |
| France | |
| Hôpital Européen Georges Pompidou | 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 | |
| Principal Investigator: | Emmanuel MESSAS, MD | Hôpital Européen Georges-Pompidou |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 16, 2019 | ||||||||
| First Posted Date ICMJE | May 20, 2019 | ||||||||
| Last Update Posted Date | September 14, 2020 | ||||||||
| Actual Study Start Date ICMJE | January 8, 2020 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging | ||||||||
| Official Title ICMJE | 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. |
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| 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Takayasu Arteritis | ||||||||
| Intervention ICMJE | 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.
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 1, 2021 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03956394 | ||||||||
| Other Study ID Numbers ICMJE | 2017-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | French Cardiology Society | ||||||||
| Study Sponsor ICMJE | French Cardiology Society | ||||||||
| Collaborators ICMJE | Institut National de la Santé Et de la Recherche Médicale, France | ||||||||
| Investigators ICMJE |
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| PRS Account | French Cardiology Society | ||||||||
| Verification Date | September 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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