Cerebral Amyloid AngiopathycSAHNCT04825808
Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.
An observational study of Cerebral Amyloid Angiopathy and Subarachnoid Hemorrhage, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy, Subarachnoid Hemorrhage
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 29 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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),
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- usual care
- Medical subject headings
- Cerebral Amyloid Angiopathy, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
according to recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of MRI
Extent of acute cSAH (number of sulci, focal [≤3 sulci] or diffuse [>3 sulci], surface)
Measured: 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)
Measured: day of the diagnosis
Description of MRI
cerebral microbleeds (CMB, <10 mm) presence
Measured: day of the diagnosis
Description of MRI
cerebral microbleeds number
Measured: day of the diagnosis
Description of MRI
cerebral microbleeds categorisation (according to the Microbleed Anatomical Rating Scale),
Measured: day of the diagnosis
Description of MRI
presence and number of chronic lobar intracerebral haemorrhage (ICH) (>10 mm)
Measured: day of the diagnosis
Description of MRI
Extent of white matter hyperintensities (periventricular Fazekas scale 0-3)
Measured: day of the diagnosis
Clinical parameters
Transient focal neurological episode (TFNE) presence
Measured: day of the diagnosis
Clinical parameters
number of TFNE preceding MRI
Measured: day of the diagnosis
Clinical parameters
TFNE symptoms (sensory, motor, visual, speech; positive or negative symptoms
Measured: day of the diagnosis
Clinical parameters
Presence and speed of spreading TFNE symptoms
Measured: day of the diagnosis
Clinical parameters
Correlation of TFNE symptoms to cSAH localisation
Measured: day of the diagnosis
Clinical parameters
headache (Yes/No)
Measured: day of the diagnosis
Clinical parameters
antiepileptic drugs (AED) introduction and type of AED introduced
Measured: day of the diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Feb 2021
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825808
- Sponsor's protocol ID
- Local/2021/DR-01
- Acronym
- cSAH
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36241843
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.
- ClinicalTrials.gov ID
- NCT04825808
- Acronym / sponsor ID
- cSAH / Local/2021/DR-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: usual careConsecutive 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥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),
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual careaccording to recommendations | Other | Patients |
Primary outcome
Description of MRI
Time frame: day of the diagnosis
Extent of acute cSAH (number of sulci, focal [≤3 sulci] or diffuse [>3 sulci], surface)
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)
Description of MRI
Time frame: day of the diagnosis
cerebral microbleeds (CMB, <10 mm) presence
Description of MRI
Time frame: day of the diagnosis
cerebral microbleeds number
Description of MRI
Time frame: day of the diagnosis
cerebral microbleeds categorisation (according to the Microbleed Anatomical Rating Scale),
Description of MRI
Time frame: day of the diagnosis
presence and number of chronic lobar intracerebral haemorrhage (ICH) (>10 mm)
Description of MRI
Time frame: day of the diagnosis
Extent of white matter hyperintensities (periventricular Fazekas scale 0-3)
Clinical parameters
Time frame: day of the diagnosis
Transient focal neurological episode (TFNE) presence
Clinical parameters
Time frame: day of the diagnosis
number of TFNE preceding MRI
Clinical parameters
Time frame: day of the diagnosis
TFNE symptoms (sensory, motor, visual, speech; positive or negative symptoms
Clinical parameters
Time frame: day of the diagnosis
Presence and speed of spreading TFNE symptoms
Clinical parameters
Time frame: day of the diagnosis
Correlation of TFNE symptoms to cSAH localisation
Clinical parameters
Time frame: day of the diagnosis
headache (Yes/No)
Clinical parameters
Time frame: day of the diagnosis
antiepileptic drugs (AED) introduction and type of AED introduced
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 36241843Autieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Amyloid Angiopathy and Subarachnoid Hemorrhage, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of MRI (time frame: day of the diagnosis). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.