Takayasu ArteritisTAK-UFNCT03956394
Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging
A study testing UltraFast ultrasound in people with Takayasu Arteritis, run by French Cardiology Society at 1 site in France.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takayasu Arteritis
- What is being tested?
- UltraFast ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Takayasu disease diagnosed according to the American College of Rheumatology 1990 criteria
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Takayasu Arteritis
- Being tested
- UltraFast ultrasound
- Keywords
- Cardiovascular Diseases, Vascular Diseases
- Medical subject headings
- Takayasu Arteritis, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraFast ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: UltraFast ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Dosage of C-reactive protein
Evaluate relation between C-reactive protein quantity and the ultrafast imaging results
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start8 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of 10 patients with active Takayasu disease, and 10 with non-active Takayasu disease.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel MESSAS, MD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956394
- Sponsor's protocol ID
- 2017-02
- Acronym
- TAK-UF
- Status last verified
- Mar 2022
- First submitted
- 16 May 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38488572
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT03956394
- Acronym / sponsor ID
- TAK-UF / 2017-02
- Conditions
- Takayasu Arteritis
- Keywords
- Cardiovascular Diseases, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of 10 patients with active Takayasu disease, and 10 with non-active Takayasu disease.
| Arm | Type | Receives |
|---|---|---|
| Active Takayasu disease | Other | Diagnostic Test: UltraFast ultrasoundUltraFast 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. |
| Non-active Takayasu disease | Other | Diagnostic Test: UltraFast ultrasoundUltraFast 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Takayasu disease diagnosed according to the American College of Rheumatology 1990 criteria
Key exclusion criteria (20 listed)
- Carotid damaged not related to Takayasu disease: atherosclerosis, post-radiation stenosis.
- Contraindication with the use of SonoVue®:
- Pregnancy or breastfeeding.
- Participation in another biomedical research protocol.
- Refusal or incapacitation of language or psychic to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltraFast ultrasoundThe 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. | Diagnostic test | Active Takayasu disease, Non-active Takayasu disease |
Primary outcome
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.
5 secondary outcomes
Evaluate average local elasticity of the ultrafast imaging results regarding the disease activity
Time frame: Day 1
Evaluate the carotid pulse wave velocity of the ultrafast imaging results regarding the disease activity
Time frame: Day 1
Evaluate the intima-media thickness of common carotid arteries of the ultrafast imaging results regarding the disease activity
Time frame: Day 1
Dosage of C-reactive protein
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 38488572Goudot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel MESSAS, MD principal investigator
Hôpital Européen Georges-Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraFast ultrasound in people with Takayasu Arteritis, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the vascularity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.