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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT04825808
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 27.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Amyloid Angiopathy; Subarachnoid Hemorrhage	Other: usual care

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Mar 29, 2021
• Actual Study Completion Date: Mar 29, 2021

Arms and Interventions

Arm	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.	Other: usual care; according to recommendations

Outcome Measures

Primary Outcome Measures

1. Description of MRI [day of the diagnosis]

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

2. Description of MRI [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)

3. Description of MRI [day of the diagnosis]

   cerebral microbleeds (CMB, <10 mm) presence

4. Description of MRI [day of the diagnosis]

   cerebral microbleeds number

5. Description of MRI [day of the diagnosis]

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

6. Description of MRI [day of the diagnosis]

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

7. Description of MRI [day of the diagnosis]

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

8. Clinical parameters [day of the diagnosis]

   Transient focal neurological episode (TFNE) presence

9. Clinical parameters [day of the diagnosis]

   number of TFNE preceding MRI

10. Clinical parameters [day of the diagnosis]

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

11. Clinical parameters [day of the diagnosis]

    Presence and speed of spreading TFNE symptoms

12. Clinical parameters [day of the diagnosis]

    Correlation of TFNE symptoms to cSAH localisation

13. Clinical parameters [day of the diagnosis]

    headache (Yes/No)

14. Clinical parameters [day of the diagnosis]

    antiepileptic drugs (AED) introduction and type of AED introduced

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT04825808
• Other Study ID Numbers: Local/2021/DR-01
• First Posted: Apr 1, 2021
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; Hemorrhage

Study Results

No Results Posted as of Apr 1, 2021