Clinical trial NCT04825808: Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.
Official title: Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Amyloid Angiopathy
Subarachnoid Hemorrhage
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Description of MRI
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
measure: Clinical parameters
timeFrame: day of the diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
citation: 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.