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

Stroke Clinical Trial

Official title:

Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation: a Comparison With Plaque Histological Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134493
• Other study ID #: 176/2018/OSS/AOUMO - MESTCD
• Status: Completed
• Start date: June 27, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2021
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Artery Plaque
• Carotid Atherosclerosis
• Carotid Stenosis
• Stroke

Locations

Country	Name	City	State
Italy	OCB Baggiovara, AOU Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MES COUNT	number of MES	before surgery
Primary	MES COUNT	number of MES	24 hours after surgery
Primary	MES COUNT	number of MES	after 30 days from the surgery
Secondary	RISK RATE	Estimate an association between MES count and plaque's histology	through study completion, an average of 60 days