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CompletedNCT04825808cSAHUpdated Apr 1, 2021

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

An observational study in Cerebral Amyloid Angiopathy and Subarachnoid Hemorrhage, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
55 Years and older
Sex
All
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Study summary

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.

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Conditions studied

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In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's enrollment of 50 is below the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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 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)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: usual care

Interventions

  • Otherusual care

    according to recommendations

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What researchers measure

Primary outcomes

  1. Description of MRI

    Extent of acute cSAH (number of sulci, focal \[≤3 sulci\] or diffuse \[\>3 sulci\], surface)

    Time frame: day of the diagnosis

  2. Description of MRI

    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)

    Time frame: day of the diagnosis

  3. Description of MRI

    cerebral microbleeds (CMB, \<10 mm) presence

    Time frame: day of the diagnosis

  4. Description of MRI

    cerebral microbleeds number

    Time frame: day of the diagnosis

  5. Description of MRI

    cerebral microbleeds categorisation (according to the Microbleed Anatomical Rating Scale),

    Time frame: day of the diagnosis

  6. Description of MRI

    presence and number of chronic lobar intracerebral haemorrhage (ICH) (\>10 mm)

    Time frame: day of the diagnosis

  7. Description of MRI

    Extent of white matter hyperintensities (periventricular Fazekas scale 0-3)

    Time frame: day of the diagnosis

  8. Clinical parameters

    Transient focal neurological episode (TFNE) presence

    Time frame: day of the diagnosis

  9. Clinical parameters

    number of TFNE preceding MRI

    Time frame: day of the diagnosis

  10. Clinical parameters

    TFNE symptoms (sensory, motor, visual, speech; positive or negative symptoms

    Time frame: day of the diagnosis

  11. Clinical parameters

    Presence and speed of spreading TFNE symptoms

    Time frame: day of the diagnosis

  12. Clinical parameters

    Correlation of TFNE symptoms to cSAH localisation

    Time frame: day of the diagnosis

  13. Clinical parameters

    headache (Yes/No)

    Time frame: day of the diagnosis

  14. Clinical parameters

    antiepileptic drugs (AED) introduction and type of AED introduced

    Time frame: day of the diagnosis

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Study locations

1 site
  • CHU de Nîmes
    Nîmes, 30029, France
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References and documents

Publications

  • Autieri V, Gaillard N, Mourand I, Laurent-Chabalier S, Mura T, Trandafir C, Wacongne A, de Champfleur NM, Thouvenot E, Pereira F, Renard D. Primary acute convexity subarachnoid hemorrhage in older patients: analysis of baseline, clinical and MRI characteristics including quantitative surface study and topographical probabilistic mapping of convexity subarachnoid hemorrhage. Acta Neurol Belg. 2023 Apr;123(2):519-527. doi: 10.1007/s13760-022-02115-8. Epub 2022 Oct 14. PubMed 36241843 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04825808
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Feb 1, 2021
Primary completion
Mar 29, 2021
Completion
Mar 29, 2021
Last update
Apr 1, 2021

Study contacts

Anissa MEGZARI
study director · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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