NCT05134493

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

Completed Last updated 26 November 2021

What this trial tests

trial in Carotid Stenosis in 120 participants. Completed in 30 June 2021.

Timeline

27 June 2018

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria di Modena
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	27 June 2018
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Italy

Conditions studied

• Carotid Stenosis — all drugs for Carotid Stenosis →
• Carotid Artery Diseases — all drugs for Carotid Artery Diseases →
• Carotid Atherosclerosis — all drugs for Carotid Atherosclerosis →
• Carotid Artery Plaque — all drugs for Carotid Artery Plaque →

Sponsor

Azienda Ospedaliero-Universitaria di Modena — full company profile →

Who can join

18 and older, any sex, with Carotid Stenosis or Carotid Artery Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Transcranial Doppler detects micro emboli in patients with asymptomatic carotid stenoses undergoing endarterectomy.
   Pizzarelli G, Gennai S, Leone N, Covic T, et al · · 2023 · cited 5× · PMID 36243263 · DOI 10.1016/j.jvs.2022.10.003