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

NCT05134493 | Completed DMC

• 1 other identifier: 176/2018/OSS/AOUMO - MESTCD
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis; Carotid Artery Diseases; Carotid Atherosclerosis; Carotid Artery Plaque; TCD; Stroke

Keywords

carotid; carotid stenosis; plaque; stroke risk; transcranial doppler; TCD; histology

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• RISK RATE

  through study completion, an average of 60 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

OCB Baggiovara, AOU Modena

Modena, 41126, Italy

Location

Related Publications (1)

• 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.

  PMID: 36243263 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

carotid plaque

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Stroke; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Moratto, Dr

  AOU Modena e Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ginevra Pizzarelli, Medico in Formazione Specialistica

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: November 26, 2021
• Study Start: June 27, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)