Microembolisation After Carotid Revascularisation

October 5, 2017 updated by: Loraine Fisch, University Hospital, Geneva

Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization

Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation occurring during revascularization procedures is associated with an increased risk of peri- and post-procedural stroke, transient ischemic attack as well as neurocognitive decline. Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.

However little is known regarding the correlation between the morphological characteristics of the carotid plaque and the occurrence of microembolisation during the procedure and between microembolisation and midterm cognitive impairment. A few studies suggest that plaque morphology may be an important determinant for the increased risk of microembolisation. These studies however have mainly investigated microembolisation occurring during CAS and exploratory studies comparing the two procedures are still lacking.

The purpose of the present study is to determine the correlation between the morphological characteristics of the carotid plaque and cerebral microembolisation either after carotid stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Screening of a carotid plaque is part of a routine procedure for patients admitted for stroke or TIA and includes ultrasound, CT-scan and MRI. Patients presenting a symptomatic or asymptomatic carotid stenosis are routinely discussed within a multidisciplinary meeting and the most appropriate therapeutic option is decided. For some patients, surgery and stenting are equivalent options. In that case, the patient may be a candidate for the present study

Description

Inclusion Criteria:

  • Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99% (according to NASCET and ECST criteria)
  • Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to NASCET and ECST criteria) Patients who accept the informed consent

Exclusion Criteria:

  • Important neurological deficit with NIHSS >7 (or severe aphasia) at time of inclusion
  • Previous known cognitive impairment
  • Pregnancy

  • Presence of contraindication based on ground of multidisciplinary team decision:

    • For surgery:

High bifurcation Intracranial extension of the carotid stenosis Patients with tandem lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the cervical region Patients with restenosis after endarterectomy

  • For stenting; Excessive arch vessel or carotid artery tortuosity and in particular presence tortuosity ≤90 degrees in the cervical segment Excessive aortic arch plaque burden Patients older than 70 years Unfavourable anatomic disposition as described above Co-morbidities that may preclude the use of a periprocedural dual antiplatelet regime.
  • For CT-scan Iodine allergy Renal insufficiency
  • For MRI Pacemaker Any other metallic implants Claustrophobia
  • For ultrasound Bad quality ultrasound (patient morphology or equipments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery group
This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis.
Diagnostic test: MRI
Diffusion weighted imaging 24 hours after revascularisation
Stenting group
This patient's group will benefit from a stenting of their carotid in order to treat their stenosis.
Diagnostic test: MRI
Diffusion weighted imaging 24 hours after revascularisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral microembolisation
Time Frame: 24 hours
the presence of at least 1 new hyperintense DWI lesion on the MRI realized within the 24 hours after procedure and will be correlated to the different characteristics of the carotid plaque evaluation.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological assessment
Time Frame: 3 months
Number and locations (watershed versus territorial) of the microembolisation will be dentified on DW-MRI and will be correlated to the neuropsychological changes after the procedure
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Loraine Fisch, Junior consultant, neurovascular unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2017

Primary Completion (ANTICIPATED)

March 30, 2019

Study Completion (ANTICIPATED)

March 30, 2019

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (ACTUAL)

October 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLASTIS

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

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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