Cerebral InfarctionCUSCASNCT03115242
Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke
A study testing Contrast injection Sonovue® in people with Cerebral Infarction, run by Versailles Hospital at 1 site in France.
Trial summary
This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Contrast injection Sonovue®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to Aug 2017
- 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
- All patients aged at least 18 years hospitalized with ischemic stroke signs in the carotid territory, objectified on brain MRI with positive DWI.
- Carotid plaque > 2.5 mm thickness in the ipsilateral carotid territory to the AIC, low echogenicity (Type 1, 2, 3, and 4a of the classification Geroulakos) measured by the assessment "GSM" (median gray level).
- Free and informed consent patient or his representative for contrast injection microbubble.
- Affiliated to health insurance.
Who cannot join
- Severe cerebral infarction with NIHSS> 25
- No-indications to the contrast medium injection
- Recent myocardial infarction, unstable angina.
- Heart failure stage III / IV New York Heart Association.
- Cardiac shunt left-right, respiratory distress.
- Allergy to albumin or contrast agents.
- Carotid plaques and hyperechoic calcified (however these plaques will be counted to determine their prevalence in acute AIC).
- Carotid dissection
Trial locations and contacts
1 site in 1 country.
About this study
This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque.
Read the detailed description
The main objective of this study is to evaluate the prevalence of the contrast taking carotid plaques in these acute ischemic strokes.
The secondary objectives are:
- to determine the clinical, sonographic, CT scanner and MRI characteristics of patients in constituted acute cerebral ischemia with carotid atherosclerotic plaque taking contrast to the doppler ultrasound.
- to explore of the plaque contrast enhancement at 6 months (new injection).
- Conditions
- Cerebral Infarction
- Being tested
- Contrast injection Sonovue®
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast injection Sonovue®Other
In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic carotid stroke | Experimental | Patients hospitalized in the neurovascular intensive care unit for an acute ischemic stroke with a carotid plaque responding to inclusion criteria.
These patients receive a contrast injection Sonovue® will be performed during the neck vessels doppler ultrasound. Receives: Other: Contrast injection Sonovue® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast enhancement of carotid plaque prevalence in ultrasound doppler
Measured: Day 1
Secondary outcomes (5)
Patient's demographics data
Measured: Day 1
Patient's sonographic and MRI characteristics.
confirmation of the recent character of stroke on the DWI, search for stroke sequelae and white matter disease on the FLAIR, search of the thrombus on the T2*, search occluded artery on the 3DTOF
Measured: Day1
describe the aspect of the carotid plaque on CT angiography.
NASCET stenosis and the aspect (smooth, irregular, ulcerated)
Measured: between 1 to 5 days
Persistence , decrease or loss of contrast enhancement in ultrasound doppler.
Measured: Month 6
Cerebral infarction recurrence
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startAug 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jennifer YEUNG (neurologist), Aurélien MAURIZOT (angiologist), Simon CHABAY (angiologist), Daniela STANCIU (neurologist)
- Responsible party
- Principal investigator, Dr Jean-Michel BAUD, Versailles Hospital
- Investigators
- Jennifer YEUNG, Neurologist, Principal investigator, Versailles HospitalJean-Michel BAUD, Angiologist, Principal investigator, Versailles HospitalAurélien MAURIZOT, Angiologist, Versailles HospitalSimon CHABAY, Angiologist, Versailles HospitalDaniela STANCIU, Neurologist, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115242
- Sponsor's protocol ID
- P14/06_CUSCAS
- Other IDs
- 2014-A01181-46
- Acronym
- CUSCAS
- Status last verified
- Mar 2018
- First submitted
- 5 Sep 2016
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03115242
- Acronym / sponsor ID
- CUSCAS / P14/06_CUSCAS
- Conditions
- Cerebral Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- Jennifer YEUNG (neurologist), Aurélien MAURIZOT (angiologist), Simon CHABAY (angiologist), Daniela STANCIU (neurologist)
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Apr 2017 (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.
This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque.
Detailed description
The main objective of this study is to evaluate the prevalence of the contrast taking carotid plaques in these acute ischemic strokes.
The secondary objectives are:
- to determine the clinical, sonographic, CT scanner and MRI characteristics of patients in constituted acute cerebral ischemia with carotid atherosclerotic plaque taking contrast to the doppler ultrasound.
- to explore of the plaque contrast enhancement at 6 months (new injection).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic carotid stroke | Experimental | Other: Contrast injection Sonovue®Patients hospitalized in the neurovascular intensive care unit for an acute ischemic stroke with a carotid plaque responding to inclusion criteria. These patients receive a contrast injection Sonovue® will be performed during the neck vessels doppler ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients aged at least 18 years hospitalized with ischemic stroke signs in the carotid territory, objectified on brain MRI with positive DWI.
- Carotid plaque > 2.5 mm thickness in the ipsilateral carotid territory to the AIC, low echogenicity (Type 1, 2, 3, and 4a of the classification Geroulakos) measured by the assessment "GSM" (median gray level).
- Free and informed consent patient or his representative for contrast injection microbubble.
- Affiliated to health insurance.
Key exclusion criteria (8 listed)
- Severe cerebral infarction with NIHSS> 25
- No-indications to the contrast medium injection
- Recent myocardial infarction, unstable angina.
- Heart failure stage III / IV New York Heart Association.
- Cardiac shunt left-right, respiratory distress.
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 |
|---|---|---|
| Contrast injection Sonovue®In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound. | Other | Acute ischemic carotid stroke |
Primary outcome
Contrast enhancement of carotid plaque prevalence in ultrasound doppler
Time frame: Day 1
5 secondary outcomes
Patient's demographics data
Time frame: Day 1
Patient's sonographic and MRI characteristics.
Time frame: Day1
describe the aspect of the carotid plaque on CT angiography.
Time frame: between 1 to 5 days
Persistence , decrease or loss of contrast enhancement in ultrasound doppler.
Time frame: Month 6
Cerebral infarction recurrence
Time frame: Month 6
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 15 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer YEUNG, Neurologist principal investigator
Versailles Hospital
Jean-Michel BAUD, Angiologist principal investigator
Versailles Hospital
Aurélien MAURIZOT, Angiologist
Versailles Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast injection Sonovue® in people with Cerebral Infarction, run by Versailles Hospital 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 4 inclusion and 8 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 15 Mar 2018. 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?
Contrast enhancement of carotid plaque prevalence in ultrasound doppler (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2018.