Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients. (cSAH)

Transient focal neurological episode (TFNE) is the most frequent presenting symptom of convexity subarachnoid haemorrhage (cSAH) in elderly patients with non-traumatic cSAH with suspected, possible or probable cerebral amyloid angiopathy (CAA). The aim of our study was to analyse in detail clinical and MRI characteristics in these patients.

Methods: We performed a retrospective study analysing baseline, acute clinical symptom (TFNE and headache), and MRI characteristics (acute cSAH and chronic CAA features) of consecutive elderly (≥55 years) patients, recruited and registered in the stroke database, between june 2008 and october 2020 of two centres (Nîmes and Montpellier University Hospital, France), presenting with cSAH with suspected, possible, or probable CAA.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

      • Nîmes, France, 30029
        • CHU de NIMES

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive elderly (≥55 years) patients, recruited and registered in the stroke database of two centres (Nîmes University Hospital and Montpellier University Hospital, France), presenting with cSAH with suspected, possible, or probable CAA.

The patients were classified as possible or probable CAA according to the modified Boston criteria. Since cortical superficial siderosis (CSS), incorporated in the modified Boston criteria, is probable a result of an earlier acute cSAH, we considered patients with acute cSAH in the absence of other typical CAA-related haemorragic features as patients with suspected CAA.

Description

Inclusion Criteria:

  • ≥55 years of age,
  • acute symptomatic cSAH based on FLAIR and T2*-weighted imaging performed within one month of symptom onset, recent trauma,
  • anticoagulation treatment, pathological blood coagulation tests (activated partial thromboplastin time [aPTT] ratio=patient's aPTT/normal control aPTT] >1.2; or partial thromboplastin time [PTT] <75%) or platelet count (<100 x 109/L),

Exclusion Criteria:

  • exclusion of underlying non-CAA cSAH causes (e.g. reversible cerebral vasoconstriction syndrome, trauma, cerebral venous sinus thrombosus, aneurysm, primary angiitis of the central nervous system, anticoagulation treatment, pathological blood coagulation tests)

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Consecutive elderly (≥55 years) patients, recruited and registered in the stroke database of two centres (Nîmes University Hospital and Montpellier University Hospital, France), presenting with cSAH with suspected, possible, or probable CAA.
according to recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of MRI
Time Frame: day of the diagnosis
Extent of acute cSAH (number of sulci, focal [≤3 sulci] or diffuse [>3 sulci], surface)
day of the diagnosis
Description of MRI
Time Frame: day of the diagnosis
the multifocality of acute cSAH (as described for cortical superficial siderosis (CSS)), sulci involved by cSAH, CSS presence, CSS extent (focal, ≤3 sulci; diffuse >3 sulci)
day of the diagnosis
Description of MRI
Time Frame: day of the diagnosis
cerebral microbleeds (CMB, <10 mm) presence
day of the diagnosis
Description of MRI
Time Frame: day of the diagnosis
cerebral microbleeds number
day of the diagnosis
Description of MRI
Time Frame: day of the diagnosis
cerebral microbleeds categorisation (according to the Microbleed Anatomical Rating Scale),
day of the diagnosis
Description of MRI
Time Frame: day of the diagnosis
presence and number of chronic lobar intracerebral haemorrhage (ICH) (>10 mm)
day of the diagnosis
Description of MRI
Time Frame: day of the diagnosis
Extent of white matter hyperintensities (periventricular Fazekas scale 0-3)
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
Transient focal neurological episode (TFNE) presence
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
number of TFNE preceding MRI
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
TFNE symptoms (sensory, motor, visual, speech; positive or negative symptoms
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
Presence and speed of spreading TFNE symptoms
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
Correlation of TFNE symptoms to cSAH localisation
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
headache (Yes/No)
day of the diagnosis
Clinical parameters
Time Frame: day of the diagnosis
antiepileptic drugs (AED) introduction and type of AED introduced
day of the diagnosis

Collaborators and Investigators

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

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.

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)

February 1, 2021

Primary Completion (Actual)

March 29, 2021

Study Completion (Actual)

March 29, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

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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