Internal Carotid ArteryEVA3MNCT05190510
Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis
An observational study of Internal Carotid Artery and Atheromatous Stenosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cerebrovascular accidents (CVA) are the second leading cause of death in France, and the most frequent cause of acquired physical and mental disability. Up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Carotid Artery, Atheromatous Stenosis
- What is being tested?
- Data collection, collection of the carotid plaque (surgical specimen) and anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2022to 26 Jan 2023
- Phase
- Observational
- 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
Study population: Scheduled surgery
Who may be able to join
- Patients with symptomatic or asymptomatic atheromatous stenosis of the internal carotid artery, of a degree ≥ 50%, for which an operative indication is retained
- Scheduled surgery
Who cannot join
- Samples collected from patients :
- who did not have a preoperative CT angiogram of the supra-aortic trunks
- with contraindication to MRI
- with contraindication to PET scan
- with a history of cervical radiotherapy
- with uncontrolled diabetes
Show all 10Show fewer
- with a previous homolateral carotid endarterectomy
- who has already undergone angioplasty-stenting of the homolateral carotid artery
- with a neoplasia considered active / not cured
- Surgical procedure performed in emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis Pilot Study
Cerebrovascular accidents (CVA) are the second leading cause of death in France, and the most frequent cause of acquired physical and mental disability. Up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid artery.
For many years, only the degree of stenosis was used to assess the risk of stroke, based on the results of original studies from the 1990s. However, the significant improvement in medical treatments since then has significantly reduced the risk of stroke, and the benefits of carotid intervention are becoming increasingly debatable.
Since the publication of the latest recommendations, the degree of stenosis alone is no longer sufficient to propose an intervention, since most of them will never lead to a neurological event. In addition to stenosis greater than 60%, for the first time, other criteria must be sought to decide on treatment. For example, so-called carotid plaque "vulnerability" criteria, defining patients "at high risk of stroke," should be sought.
- Conditions
- Internal Carotid Artery, Atheromatous Stenosis
- Being tested
- Data collection, collection of the carotid plaque (surgical specimen), anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection of data from preoperative imaging examinations (routine examination prescribed before the operation)
collection of the carotid plaque (surgical specimen)Procedure or surgery
collection of the carotid plaque
anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimensOther
anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens
| Study group | Role | What they receive |
|---|---|---|
| Patient with atheromatous stenosis of the internal carotid artery | Not described Receives: Other: Data collection; Procedure: collection of the carotid plaque (surgical specimen); Other: anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of 18FDG tracer uptake in carotid stenosis
Measured: At baseline
Degree of instability of the plate
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start14 Feb 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Why it stopped: The carotid plaque is too small to quantify activity with the standard protocol used, despite a rigorous protocol and methodology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Carotid ArteryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190510
- Sponsor's protocol ID
- STEINMETZ 2021
- Acronym
- EVA3M
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis Pilot Study
- ClinicalTrials.gov ID
- NCT05190510
- Acronym / sponsor ID
- EVA3M / STEINMETZ 2021
- Conditions
- Internal Carotid Artery, Atheromatous Stenosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The carotid plaque is too small to quantify activity with the standard protocol used, despite a rigorous protocol and methodology.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 13 Jan 2022 (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.
Cerebrovascular accidents (CVA) are the second leading cause of death in France, and the most frequent cause of acquired physical and mental disability. Up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid artery.
For many years, only the degree of stenosis was used to assess the risk of stroke, based on the results of original studies from the 1990s. However, the significant improvement in medical treatments since then has significantly reduced the risk of stroke, and the benefits of carotid intervention are becoming increasingly debatable.
Since the publication of the latest recommendations, the degree of stenosis alone is no longer sufficient to propose an intervention, since most of them will never lead to a neurological event. In addition to stenosis greater than 60%, for the first time, other criteria must be sought to decide on treatment. For example, so-called carotid plaque "vulnerability" criteria, defining patients "at high risk of stroke," should be sought.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with atheromatous stenosis of the internal carotid artery | – | Other: Data collection, Procedure: collection of the carotid plaque (surgical specimen), Other: anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Scheduled surgery
Key inclusion criteria (2 listed)
- Patients with symptomatic or asymptomatic atheromatous stenosis of the internal carotid artery, of a degree ≥ 50%, for which an operative indication is retained
- Scheduled surgery
Key exclusion criteria (10 listed)
- who did not have a preoperative CT angiogram of the supra-aortic trunks
- with contraindication to MRI
- with contraindication to PET scan
- with a history of cervical radiotherapy
- with uncontrolled diabetes
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 |
|---|---|---|
| Data collectionCollection of data from preoperative imaging examinations (routine examination prescribed before the operation) | Other | Patient with atheromatous stenosis of the internal carotid artery |
| collection of the carotid plaque (surgical specimen)collection of the carotid plaque | Procedure or surgery | Patient with atheromatous stenosis of the internal carotid artery |
| anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimensanatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens | Other | Patient with atheromatous stenosis of the internal carotid artery |
Primary outcome
rate of 18FDG tracer uptake in carotid stenosis
Time frame: At baseline
Degree of instability of the plate
Time frame: At baseline
Results and safety
The study was stopped early (reason given: The carotid plaque is too small to quantify activity with the standard protocol used, despite a rigorous protocol and methodology.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Carotid Artery and Atheromatous Stenosis, run by Centre Hospitalier Universitaire Dijon 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 Jul 2024. 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 was stopped early (reason given: The carotid plaque is too small to quantify activity with the standard protocol used, despite a rigorous protocol and methodology.). Results are not available in the source record.
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?
rate of 18FDG tracer uptake in carotid stenosis (time frame: At baseline). The study lists 2 primary outcomes in all. 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 30 Jul 2024.