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

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Completed
CT.gov ID
NCT05134493
Collaborator
(none)
120
1
36.1
3.3

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation: a Comparison With Plaque Histological Findings
Actual Study Start Date :
Jun 27, 2018
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. MES COUNT [before surgery]

    number of MES

  2. MES COUNT [24 hours after surgery]

    number of MES

  3. MES COUNT [after 30 days from the surgery]

    number of MES

Secondary Outcome Measures

  1. RISK RATE [through study completion, an average of 60 days]

    Estimate an association between MES count and plaque's histology

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 OCB Baggiovara, AOU Modena Modena Italy 41126

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

Investigators

  • Principal Investigator: Roberto Moratto, Dr, AOU Modena e Reggio Emilia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ginevra Pizzarelli, Dr. Ginevra Pizzarelli, Medico in Formazione Specialistica, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier:
NCT05134493
Other Study ID Numbers:
  • 176/2018/OSS/AOUMO - MESTCD
First Posted:
Nov 26, 2021
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ginevra Pizzarelli, Dr. Ginevra Pizzarelli, Medico in Formazione Specialistica, Azienda Ospedaliero-Universitaria di Modena
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 26, 2021