Clinical trial NCT05134493: Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation
Official title: Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation: a Comparison With Plaque Histological Findings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Carotid Artery Diseases
Carotid Atherosclerosis
Carotid Artery Plaque
TCD
Stroke
Keywords: carotid
carotid stenosis
plaque
stroke risk
transcranial doppler
TCD
histology
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We selected patients already got in touch with the hospital, already put in list for a carotid surgical revascularization.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed
* Age\>18y.o.
* Carotid stenosis \>70% and/or vulnerable plaque

Exclusion Criteria:

* 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

Primary outcomes:
measure: MES COUNT
timeFrame: before surgery
measure: MES COUNT
timeFrame: 24 hours after surgery
measure: MES COUNT
timeFrame: after 30 days from the surgery
Secondary outcomes:
measure: RISK RATE
timeFrame: through study completion, an average of 60 days
Other outcomes:
Locations:
city: Modena
country: Italy
facility: OCB Baggiovara, AOU Modena
Study officials:
affiliation: AOU Modena e Reggio Emilia
name: Roberto Moratto, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.