Carotid StenosisNCT05134493
Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation
An observational study of Carotid Stenosis and Carotid Artery Diseases, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
About 20% of strokes are caused by emboli deriving from a carotid plaque. In symptomatic patients with carotid stenosis grater than 70% the Carotid Endarterectomy (CEA) reduces stroke risk by about 75% and is generally accepted as being cost effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2018to 30 Jun 2021
- 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: We selected patients already got in touch with the hospital, already put in list for a carotid surgical revascularization.
Who may be able to join
- Informed consent signed
- Age>18y.o.
- Carotid stenosis >70% and/or vulnerable plaque
Who cannot join
- Inability to give the informed consent
- Age<18y.o.
- Carotid stenosis < 70 %
- Patients already treated with CEA in the same seat
- Impossibility to find the insonation window
- Patients not in best medical treatment therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation: a Comparison With Plaque Histological Findings
About 20% of strokes are caused by emboli deriving from a carotid plaque. In symptomatic patients with carotid stenosis grater than 70% the Carotid Endarterectomy (CEA) reduces stroke risk by about 75% and is generally accepted as being cost effective. However also in these cases there is a part of the population that, according to the morphological plaque characteristics, could better benefit from a conservative medical treatment.
Improving the Best Medical Treatment, the situation seems to be even less clear in asymptomatic patients, where probably it would need to treat at least 32 patients in order to prevent one single ictus.
Read more
Different parameters have been considered in order to determine, among the asymptomatic patients the ones that more than others could benefit from a surgical revascularisation instead of a medical treatment.
Between these parameters, the quality of the plaque (vulnerability) and the micro-embolic signals (MES) detection with the Transcranial Doppler (TCD) Holter seems to be the most relevant.
Another interesting aspect is trying to establish whether plaques can determine a different embolic risk in relation to the different histological findings.
Therefore, it seems interesting and reasonable trying to establish a correlation between these two parameters in asymptomatic patients as in the symptomatic ones in order to make more and more appropriate a surgical plaque removal according to the specific risk of each patient in a set of tailored surgery.
It consists in a descriptive observational study, since it intends to describe the embolic signals detection (MES) counted in automatic way with the TCD Holter, in patients affected by carotid stenosis, before and after the surgical operation.
In particular it consists in a monocentric, longitudinal, prospective cohort study since it intends to analyse a group of patients (already candidates to CEA) that experiences a specific event (MES) before and after the surgical plaque removal, in a precise span of time.
Since the treatment, removing the plaque, should remove the embolic focus too, a significant reduction of microembolic signals in post-operative time is expected.
This reduction has been esteemed around about the 70% among candidates to CEA. Patients taken on responsibility of the equipe will undergo an ultrasonographic investigation for the carotid stenosis, histological characterization of the plaque based on the Gray-Weale classification and TCD-Holter for MES.
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Plaque, TCD, Stroke
- Keywords
- carotid, carotid stenosis, plaque, stroke risk, transcranial doppler, TCD, histology
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases, Stroke, Plaque, Amyloid
What is being measured
The primary outcome is the main question the study is designed to answer.
MES COUNT
number of MES
Measured: before surgery
MES COUNT
number of MES
Measured: 24 hours after surgery
MES COUNT
number of MES
Measured: after 30 days from the surgery
Secondary outcomes (1)
RISK RATE
Estimate an association between MES count and plaque's histology
Measured: through study completion, an average of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start27 Jun 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 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 Carotid StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ginevra Pizzarelli, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Roberto Moratto, Dr, Principal investigator, AOU Modena e Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134493
- Sponsor's protocol ID
- 176/2018/OSS/AOUMO - MESTCD
- Status last verified
- Nov 2021
- First submitted
- 25 Jun 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pizzarelli G, Gennai S, Leone N, Covic T, Moratto R, Silingardi R. Transcranial Doppler detects micro emboli in patients with asymptomatic carotid stenoses undergoing endarterectomy. J Vasc Surg. 2023 Mar;77(3):811-817.e2. doi: 10.1016/j.jvs.2022.10.003. Epub 2022 Oct 13.
PubMed 36243263
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation: a Comparison With Plaque Histological Findings
- ClinicalTrials.gov ID
- NCT05134493
- Acronym / sponsor ID
- 176/2018/OSS/AOUMO - MESTCD
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Plaque, TCD, Stroke
- Keywords
- carotid, carotid stenosis, plaque, stroke risk, transcranial doppler, TCD, histology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Nov 2021 (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.
About 20% of strokes are caused by emboli deriving from a carotid plaque. In symptomatic patients with carotid stenosis grater than 70% the Carotid Endarterectomy (CEA) reduces stroke risk by about 75% and is generally accepted as being cost effective. However also in these cases there is a part of the population that, according to the morphological plaque characteristics, could better benefit from a conservative medical treatment.
Improving the Best Medical Treatment, the situation seems to be even less clear in asymptomatic patients, where probably it would need to treat at least 32 patients in order to prevent one single ictus.
Different parameters have been considered in order to determine, among the asymptomatic patients the ones that more than others could benefit from a surgical revascularisation instead of a medical treatment.
Between these parameters, the quality of the plaque (vulnerability) and the micro-embolic signals (MES) detection with the Transcranial Doppler (TCD) Holter seems to be the most relevant.
Another interesting aspect is trying to establish whether plaques can determine a different embolic risk in relation to the different histological findings.
Therefore, it seems interesting and reasonable trying to establish a correlation between these two parameters in asymptomatic patients as in the symptomatic ones in order to make more and more appropriate a surgical plaque removal according to the specific risk of each patient in a set of tailored surgery.
It consists in a descriptive observational study, since it intends to describe the embolic signals detection (MES) counted in automatic way with the TCD Holter, in patients affected by carotid stenosis, before and after the surgical operation.
In particular it consists in a monocentric, longitudinal, prospective cohort study since it intends to analyse a group of patients (already candidates to CEA) that experiences a specific event (MES) before and after the surgical plaque removal, in a precise span of time.
Since the treatment, removing the plaque, should remove the embolic focus too, a significant reduction of microembolic signals in post-operative time is expected.
This reduction has been esteemed around about the 70% among candidates to CEA. Patients taken on responsibility of the equipe will undergo an ultrasonographic investigation for the carotid stenosis, histological characterization of the plaque based on the Gray-Weale classification and TCD-Holter for MES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We selected patients already got in touch with the hospital, already put in list for a carotid surgical revascularization.
Key inclusion criteria (3 listed)
- Informed consent signed
- Age>18y.o.
- Carotid stenosis >70% and/or vulnerable plaque
Key exclusion criteria (6 listed)
- Inability to give the informed consent
- Age<18y.o.
- Carotid stenosis < 70 %
- Patients already treated with CEA in the same seat
- Impossibility to find the insonation window
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MES COUNT
Time frame: before surgery
number of MES
MES COUNT
Time frame: 24 hours after surgery
number of MES
MES COUNT
Time frame: after 30 days from the surgery
number of MES
1 secondary outcome
RISK RATE
Time frame: through study completion, an average of 60 days
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 26 Nov 2021.
- Derived from this study: PubMed 36243263Pizzarelli G, Gennai S, Leone N, Covic T, Moratto R, Silingardi R. Transcranial Doppler detects micro emboli in patients with asymptomatic carotid stenoses undergoing endarterectomy. J Vasc Surg. 2023 Mar;77(3):811-817.e2. doi: 10.1016/j.jvs.2022.10.003. Epub 2022 Oct 13.
- Individual participant dataSharing planned: No
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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.
Roberto Moratto, Dr principal investigator
AOU Modena e Reggio Emilia
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 Carotid Stenosis and Carotid Artery Diseases, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 3 inclusion and 6 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 26 Nov 2021. 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 Italy. 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?
MES COUNT (time frame: before surgery). The study lists 3 primary outcomes in all. 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 NCT05134493, 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 26 Nov 2021.