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

Subarachnoid Hemorrhage Clinical Trial

— cSAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825808
• Other study ID #: Local/2021/DR-01
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: March 29, 2021

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Amyloid Angiopathy
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• usual care
according to recommendations

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of MRI	Extent of acute cSAH (number of sulci, focal [=3 sulci] or diffuse [>3 sulci], surface)	day of the diagnosis
Primary	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)	day of the diagnosis
Primary	Description of MRI	cerebral microbleeds (CMB, <10 mm) presence	day of the diagnosis
Primary	Description of MRI	cerebral microbleeds number	day of the diagnosis
Primary	Description of MRI	cerebral microbleeds categorisation (according to the Microbleed Anatomical Rating Scale),	day of the diagnosis
Primary	Description of MRI	presence and number of chronic lobar intracerebral haemorrhage (ICH) (>10 mm)	day of the diagnosis
Primary	Description of MRI	Extent of white matter hyperintensities (periventricular Fazekas scale 0-3)	day of the diagnosis
Primary	Clinical parameters	Transient focal neurological episode (TFNE) presence	day of the diagnosis
Primary	Clinical parameters	number of TFNE preceding MRI	day of the diagnosis
Primary	Clinical parameters	TFNE symptoms (sensory, motor, visual, speech; positive or negative symptoms	day of the diagnosis
Primary	Clinical parameters	Presence and speed of spreading TFNE symptoms	day of the diagnosis
Primary	Clinical parameters	Correlation of TFNE symptoms to cSAH localisation	day of the diagnosis
Primary	Clinical parameters	headache (Yes/No)	day of the diagnosis
Primary	Clinical parameters	antiepileptic drugs (AED) introduction and type of AED introduced	day of the diagnosis