Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation

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.

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 Overview

• Status: Completed
• Conditions: Stroke; Carotid Artery Plaque; Carotid Stenosis; Carotid Artery Diseases; Carotid Atherosclerosis; TCD

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41126
    • OCB Baggiovara, AOU Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MES COUNT	number of MES	before surgery
MES COUNT	number of MES	24 hours after surgery
MES COUNT	number of MES	after 30 days from the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RISK RATE	Estimate an association between MES count and plaque's histology	through study completion, an average of 60 days

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena
• Investigators: Principal Investigator: Roberto Moratto, Dr, AOU Modena e Reggio Emilia

Publications and helpful links

General 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. 2022 Oct 13:S0741-5214(22)02336-9. doi: 10.1016/j.jvs.2022.10.003. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: carotid stenosis; histology; plaque; TCD; stroke risk; carotid; transcranial doppler
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Stenosis; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: 176/2018/OSS/AOUMO - MESTCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No