NCT04442074

Brief Summary

Carotid diaphragms are a non-atheromatous arterial cause of cerebral infarction, especially in young people (≤65 years old). This anomaly is more common in the African or African-American population, although it is more and more often discovered in young Caucasians. This cause of cerebrovascular accident (CVA), known until the 1970s, was later forgotten until a recent revival of interest, probably in connection with the improvement of imagery but also by the discovery that these lesions have a high rate of recurrence in the absence of interventional care. In a Brazilian study, the carotid diaphragm was reported in 10% of patients under the age of 60. The carotid diaphragm is a non-atheromatous overgrowth of the intima of the arterial wall. It appears in imagery in the form of an endoluminal web wider than it is tall. Its preferred seat is the carotid bulb. It is a source, by an embologenic mechanism, of cerebral infarction starting from local thrombus developed within large cerebral arteries. In histology, the lesions are different from atherosclerosis and characterized by a thickening of the intima with proliferation of loose and strewed spindle cells mainly involving the intima. An atheromatous plaque or dissection with detachment of the intima are the two main differential diagnoses of the carotid web. However, the appearance of a diaphragm implanted on a regular wall and the absence of any other localization of atheroma distinguish the lesion of the carotid web from that of a focal atheromatous plate. In addition, the very proximal localization of the carotid web, from the emergence of the internal carotid artery, does not suggest a dissection, the localization of which is usually downstream of the bulb. The baseline exam to detect a carotid diaphragm is a carotid angiography scan, but the abnormalities are often inconspicuous, making diagnosis difficult. We can be led in case of doubt to perform a conventional arteriography, which remains the "gold standard". The latter, dynamic examination compared to the CT scan, shows above all a stasis of blood flow in the recess created by the diaphragm, stasis at the origin of the formation of thrombi. It has been suspected that the maximum risk of infarction is upon waking, at the time of verticalization, with mobilization of the thrombus. Therapeutically, the discovery of a symptomatic carotid diaphragm (ischemic swallowing accident) justifies radical treatment. The risk of recurrence of a patient on antithrombotic (antiplatelet or anticoagulant) being too high, it is proposed either surgery, or carotid angioplasty with stent placement. No comparative study of the 2 techniques has been carried out. Besides radiological examinations, ultrasound is another technique for studying the cervical arteries. It is reputed to be of little contribution in the search for a carotid diaphragm, but few publications exist to date even though the cervical Doppler is often the first arterial examination carried out after an ischemic stroke. Two series reported Doppler ultrasound data in the carotid diaphragm. A recent retrospective study evaluated, in multimodal imaging \[Doppler, CT scan of the Supra-Aortic Trunks (ASD) and conventional arteriography\], 30 patients (60 carotids) with diaphragm or atherosclerosis. The correlation between conventional arteriography and CT angiography was perfect, but the correlation between Doppler and CT angiography for diaphragm diagnosis was moderate. In another series studying 15 diaphragms diagnosed by CT angiography, the retrospective analysis of doppler reports revealed that 40% were considered normal and 60% mentioned nonspecific hyperechoic lesions, but this work remained in the form of a presentation. at a congress. With the improvement of the technique and the resolution of the Doppler ultrasound as well as the knowledge of the particular ultrasound characteristics, it seems to us that this examination could regain a place in the diagnosis of the pathology. The carotid diaphragm is also largely unknown to vascular doctors practicing cervical Doppler ultrasound. This descriptive study of the diagnostic contribution of the echo-doppler for a carotid diaphragm has for perspective the establishment of a prospective study of the contribution of a combined expertise angiologist-neurologist in the echo-Doppler for patients \<60 years hospitalized for an ischemic stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

June 17, 2020

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Doppler ultrasound sensitivity for the carotid diaphragm

    This outcome corresponds to the number of echo-doppler reports for which the diagnosis of carotid diaphragm is mentioned, correlated to the number of echo-doppler images presenting anomalies suggestive of carotid diaphragm.

    Day 1

Secondary Outcomes (2)

  • Description of Anomalies suggestive of carotid diaphragm on Doppler ultrasound

    Day 1

  • Sensitivity of the Doppler ultrasound with that of the reference vascular examinations

    Day 1

Study Arms (1)

Stroke Patients

These patients were hospitalized in the neurology / neurovascular department of the Paris Saint-Joseph Hospital Group, for the management of a transient ischemic infarction or accident for which the diagnosis of ipsilateral carotid diaphragm was accepted, between April 2017 and April 2020.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were hospitalized in the neurology / neurovascular department of the Paris Saint-Joseph Hospital Group, for the management of a transient ischemic infarction or accident for which the diagnosis of ipsilateral carotid diaphragm was accepted, between April 2017 and April 2020.

You may qualify if:

  • Patient whose age is\> 18 years old and ≤65 years old
  • Patients treated in the neurology department for an infarction or transient ischemic attack for which the diagnosis of ipsilateral carotid diaphragm was accepted, between April 2017 and April 2020
  • French speaking patients

You may not qualify if:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient objecting to the use of his data for this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

RECRUITING

Related Publications (3)

  • Haussen DC, Grossberg JA, Bouslama M, Pradilla G, Belagaje S, Bianchi N, Allen JW, Frankel M, Nogueira RG. Carotid Web (Intimal Fibromuscular Dysplasia) Has High Stroke Recurrence Risk and Is Amenable to Stenting. Stroke. 2017 Nov;48(11):3134-3137. doi: 10.1161/STROKEAHA.117.019020. Epub 2017 Oct 10.

  • Coutinho JM, Derkatch S, Potvin AR, Tomlinson G, Casaubon LK, Silver FL, Mandell DM. Carotid artery web and ischemic stroke: A case-control study. Neurology. 2017 Jan 3;88(1):65-69. doi: 10.1212/WNL.0000000000003464. Epub 2016 Nov 18.

  • Madaelil TP, Grossberg JA, Nogueira RG, Anderson A, Barreira C, Frankel M, Haussen DC. Multimodality Imaging in Carotid Web. Front Neurol. 2019 Mar 12;10:220. doi: 10.3389/fneur.2019.00220. eCollection 2019.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ruben Tamazyan, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Tamazyan, MD

CONTACT

Helene BEAUSSIER, PharmD, pHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 22, 2020

Study Start

June 13, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations