- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825808
Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients. (cSAH)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nîmes, France, 30029
- CHU de NIMES
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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according to recommendations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of MRI
Time Frame: day of the diagnosis
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Extent of acute cSAH (number of sulci, focal [≤3 sulci] or diffuse [>3 sulci], surface)
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day of the diagnosis
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Description of MRI
Time Frame: day of the diagnosis
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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)
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day of the diagnosis
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Description of MRI
Time Frame: day of the diagnosis
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cerebral microbleeds (CMB, <10 mm) presence
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day of the diagnosis
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Description of MRI
Time Frame: day of the diagnosis
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cerebral microbleeds number
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day of the diagnosis
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Description of MRI
Time Frame: day of the diagnosis
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cerebral microbleeds categorisation (according to the Microbleed Anatomical Rating Scale),
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day of the diagnosis
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Description of MRI
Time Frame: day of the diagnosis
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presence and number of chronic lobar intracerebral haemorrhage (ICH) (>10 mm)
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day of the diagnosis
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Description of MRI
Time Frame: day of the diagnosis
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Extent of white matter hyperintensities (periventricular Fazekas scale 0-3)
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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Transient focal neurological episode (TFNE) presence
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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number of TFNE preceding MRI
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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TFNE symptoms (sensory, motor, visual, speech; positive or negative symptoms
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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Presence and speed of spreading TFNE symptoms
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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Correlation of TFNE symptoms to cSAH localisation
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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headache (Yes/No)
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day of the diagnosis
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Clinical parameters
Time Frame: day of the diagnosis
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antiepileptic drugs (AED) introduction and type of AED introduced
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day of the diagnosis
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Proteostasis Deficiencies
- Metabolism, Inborn Errors
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Intracranial Hemorrhages
- Cerebral Small Vessel Diseases
- Amyloidosis, Familial
- Amyloidosis
- Hemorrhage
- Subarachnoid Hemorrhage
- Cerebral Amyloid Angiopathy
- Cerebral Amyloid Angiopathy, Familial
Other Study ID Numbers
- Local/2021/DR-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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