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Completed

NCT Number: NCT04825808

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

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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Key information

Conditions

Cerebral Amyloid Angiopathy Amyloidosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Hemorrhage Intracranial Arterial Diseases Intracranial Hemorrhages Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Subarachnoid Hemorrhage Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Usual Care

Other

according to recommendations

Primary outcomes

  1. Description of MRI

    Time frame: day of the diagnosis

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

  2. Description of MRI

    Time frame: 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

    Time frame: day of the diagnosis

    cerebral microbleeds (CMB, <10 mm) presence

  4. Description of MRI

    Time frame: day of the diagnosis

    cerebral microbleeds number

  5. Description of MRI

    Time frame: day of the diagnosis

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

  6. Description of MRI

    Time frame: day of the diagnosis

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

  7. Description of MRI

    Time frame: day of the diagnosis

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

  8. Clinical parameters

    Time frame: day of the diagnosis

    Transient focal neurological episode (TFNE) presence

  9. Clinical parameters

    Time frame: day of the diagnosis

    number of TFNE preceding MRI

  10. Clinical parameters

    Time frame: day of the diagnosis

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

  11. Clinical parameters

    Time frame: day of the diagnosis

    Presence and speed of spreading TFNE symptoms

  12. Clinical parameters

    Time frame: day of the diagnosis

    Correlation of TFNE symptoms to cSAH localisation

  13. Clinical parameters

    Time frame: day of the diagnosis

    headache (Yes/No)

  14. Clinical parameters

    Time frame: day of the diagnosis

    antiepileptic drugs (AED) introduction and type of AED introduced

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: cSAH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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