NCT04825808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 29, 2021

Last Update Submit

March 29, 2021

Conditions

Outcome Measures

Primary Outcomes (14)

  • Description of MRI

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

    day of the diagnosis

  • 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

  • Description of MRI

    cerebral microbleeds (CMB, \<10 mm) presence

    day of the diagnosis

  • Description of MRI

    cerebral microbleeds number

    day of the diagnosis

  • Description of MRI

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

    day of the diagnosis

  • Description of MRI

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

    day of the diagnosis

  • Description of MRI

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

    day of the diagnosis

  • Clinical parameters

    Transient focal neurological episode (TFNE) presence

    day of the diagnosis

  • Clinical parameters

    number of TFNE preceding MRI

    day of the diagnosis

  • Clinical parameters

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

    day of the diagnosis

  • Clinical parameters

    Presence and speed of spreading TFNE symptoms

    day of the diagnosis

  • Clinical parameters

    Correlation of TFNE symptoms to cSAH localisation

    day of the diagnosis

  • Clinical parameters

    headache (Yes/No)

    day of the diagnosis

  • Clinical parameters

    antiepileptic drugs (AED) introduction and type of AED introduced

    day of the diagnosis

Study Arms (1)

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

according to recommendations

Patients

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Amyloid AngiopathySubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebral Arterial DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

February 1, 2021

Primary Completion

March 29, 2021

Study Completion

March 29, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations