Intracerebral HemorrhageSuSPect-CAANCT01856699
Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy
An observational study of Intracerebral Hemorrhage and Cerebral Amyloid Angiopathy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a primary focus on future stroke and mortality. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Cerebral Amyloid Angiopathy, Ischemic Stroke
- How many people
- 302 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to May 2019
- 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: hospital based
Who may be able to join
- Fulfillment of the modified Boston criteria for CAA-related hemorrhage with evidence of supratentorial superficial siderosis on MRI
- MR-/CT-/digital subtraction (DS) -angiography without evidence of cerebral aneurysm, arterio-venous malformation (AVM) , AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction)
- A maximum of two lobar or cerebellar intracranial hemorrhages (ICH) (old or acute)
- Written informed consent by patient or guardian prior to study participation
- Willingness to participate in follow-up
- Fulfillment of the classic Boston criteria for CAA-related hemorrhage
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- Absence of superficial siderosis on MRI
- A maximum of two lobar or cerebellar ICHs (old or acute)
- MR-/CT-/DS -angiography without evidence of cerebral aneurysm, AVM, AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction)
- Written informed consent by patient or guardian prior to study participation
- Willingness to participate in follow-up
Who cannot join
- Severe medical condition with expected life expectancy <3 years
- More than two lobar or cerebellar ICH (old or acute)
- any intracerebral hemorrhage in the deep grey matter (basal ganglia or thalami) or in the brain stem
- History of head trauma resulting in loss of consciousness or radiologically visible traumatic brain injury (contusions, diffuse axonal damage) in the last 5 years prior to inclusion
- Cerebral aneurysm or history of aneurysmal subarachnoid hemorrhage
- Infratentorial siderosis
- Infratentorial subarachnoid hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Prognostic Relevance of Supratentorial Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy
Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a primary focus on future stroke and mortality.
Read the detailed description
Non-traumatic cortical superficial siderosis (cSS) is a common finding in patients with cerebral amyloid angiopathy (CAA) and can be its sole imaging sign. The clinical features and course as well as the prognostic significance of cSS in CAA patients remain unclear. In a retrospective study we have previously shown that cSS might be an important predictor or warning sign for future intracranial hemorrhage. However, prospective data are missing.
The Superficial Siderosis in Patients with suspected Cerebral Amyloid Angiopathy (SuSPect-CAA) study is designed as a prospective observational multi-centre cohort study. Primary objective of the study is to evaluate if cSS is a predictor for future stroke and mortality (primary endpoint: combined rate of stroke and death after 36 months). Secondary objectives of the study include 1) to evaluate if cSS represents a marker of future intracranial haemorrhage, especially at the site of initial siderosis, 2) to describe the clinical presentation and course of cSS, 3) to assess to associated imaging findings, 4) to determine the differential diagnoses of cSS.
All subjects presenting to the respective neurological centers (out- or inpatient treatment with neuroimaging) will be screened. The study population will consist of two patient groups: 1) Patients meeting the modified Boston criteria for probable or possible CAA, i. e. patients with SS +/- lobar intracerebral hemorrhage or microbleeds in cortico-subcortical localization and absence of other cause of hemorrhage than CAA will be assigned to the study group. 2) Patients meeting the classic Boston criteria for possible or probable CAA but without any SS will be assigned to the control group. A total of 100 patients per group will be enrolled. Baseline and follow-up assessment at 6, 12, 24, and 36 months will be performed by visits in the respective neurological outpatient clinic including a structured interview and neurological exam, neuropsychological tests, EEG and MRI.
- Keywords
- supratentorial superficial siderosis, intracerebral hemorrhage, cerebral amyloid angiopathy
- Medical subject headings
- Cerebral Hemorrhage, Cerebral Amyloid Angiopathy, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients with cortical superficial siderosis and possible or probable cerebral amyloid angiopathy meeting the modified Boston criteria. | |
| Control Group | Patients with possible or probable cerebral amyloid angiopathy meeting the classic Boston criteria but without any cortical superficial siderosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined rate of stroke and death
All cause mortality and stroke (WHO-definition)
Measured: 36 months
Secondary outcomes (1)
Rate of intracranial hemorrhage
Rate of any intracranial hemorrhage as assessed by cerebral imaging
Measured: 6, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Opherk, Ludwig-Maximilians - University of Munich
- Investigators
- Frank Wollenweber, MD, Principal investigator, Institute for Stroke and Dementia Research, Ludwig-Maximilans-UniversityJennifer Linn, MD, Principal investigator, Department of Neuroradiology, Carl Carus University DresdenChristian Opherk, MD, Principal investigator, Institute for Stroke and Dementia Research, Ludwig-Maximilans-UniversityMartin Dichgans, MD, Study director, Institute for Stroke and Dementia Research, Ludwig-Maximilians-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856699
- Sponsor's protocol ID
- SuSPect-CAA
- Acronym
- SuSPect-CAA
- Status last verified
- Aug 2017
- First submitted
- 15 May 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Prognostic Relevance of Supratentorial Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy
- ClinicalTrials.gov ID
- NCT01856699
- Acronym / sponsor ID
- SuSPect-CAA / SuSPect-CAA
- Keywords
- supratentorial superficial siderosis, intracerebral hemorrhage, cerebral amyloid angiopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 17 May 2013 (estimated)
- 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.
Aim of the SuSPect-CAA study is to prospectively evaluate the prognostic significance of cortical superficial siderosis in patients with suspected cerebral amyloid angiopathy with a primary focus on future stroke and mortality.
Detailed description
Non-traumatic cortical superficial siderosis (cSS) is a common finding in patients with cerebral amyloid angiopathy (CAA) and can be its sole imaging sign. The clinical features and course as well as the prognostic significance of cSS in CAA patients remain unclear. In a retrospective study we have previously shown that cSS might be an important predictor or warning sign for future intracranial hemorrhage. However, prospective data are missing.
The Superficial Siderosis in Patients with suspected Cerebral Amyloid Angiopathy (SuSPect-CAA) study is designed as a prospective observational multi-centre cohort study. Primary objective of the study is to evaluate if cSS is a predictor for future stroke and mortality (primary endpoint: combined rate of stroke and death after 36 months). Secondary objectives of the study include 1) to evaluate if cSS represents a marker of future intracranial haemorrhage, especially at the site of initial siderosis, 2) to describe the clinical presentation and course of cSS, 3) to assess to associated imaging findings, 4) to determine the differential diagnoses of cSS.
All subjects presenting to the respective neurological centers (out- or inpatient treatment with neuroimaging) will be screened. The study population will consist of two patient groups: 1) Patients meeting the modified Boston criteria for probable or possible CAA, i. e. patients with SS +/- lobar intracerebral hemorrhage or microbleeds in cortico-subcortical localization and absence of other cause of hemorrhage than CAA will be assigned to the study group. 2) Patients meeting the classic Boston criteria for possible or probable CAA but without any SS will be assigned to the control group. A total of 100 patients per group will be enrolled. Baseline and follow-up assessment at 6, 12, 24, and 36 months will be performed by visits in the respective neurological outpatient clinic including a structured interview and neurological exam, neuropsychological tests, EEG and MRI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Patients with cortical superficial siderosis and possible or probable cerebral amyloid angiopathy meeting the modified Boston criteria. |
| Control Group | – | –Patients with possible or probable cerebral amyloid angiopathy meeting the classic Boston criteria but without any cortical superficial siderosis. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital based
Key inclusion criteria (11 listed)
- Fulfillment of the modified Boston criteria for CAA-related hemorrhage with evidence of supratentorial superficial siderosis on MRI
- MR-/CT-/digital subtraction (DS) -angiography without evidence of cerebral aneurysm, arterio-venous malformation (AVM) , AV-fistula or other pathology of relevance (e.g. tumor, hemorrhagic infarction)
- A maximum of two lobar or cerebellar intracranial hemorrhages (ICH) (old or acute)
- Written informed consent by patient or guardian prior to study participation
- Willingness to participate in follow-up
Key exclusion criteria (7 listed)
- Severe medical condition with expected life expectancy <3 years
- More than two lobar or cerebellar ICH (old or acute)
- any intracerebral hemorrhage in the deep grey matter (basal ganglia or thalami) or in the brain stem
- History of head trauma resulting in loss of consciousness or radiologically visible traumatic brain injury (contusions, diffuse axonal damage) in the last 5 years prior to inclusion
- Cerebral aneurysm or history of aneurysmal subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined rate of stroke and death
Time frame: 36 months
All cause mortality and stroke (WHO-definition)
1 secondary outcome
Rate of intracranial hemorrhage
Time frame: 6, 12, 24, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Frank Wollenweber, MD principal investigator
Institute for Stroke and Dementia Research, Ludwig-Maximilans-University
Jennifer Linn, MD principal investigator
Department of Neuroradiology, Carl Carus University Dresden
Christian Opherk, MD principal investigator
Institute for Stroke and Dementia Research, Ludwig-Maximilans-University
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 Intracerebral Hemorrhage and Cerebral Amyloid Angiopathy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. 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 Germany. 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?
Results are not available in the source record.
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?
Combined rate of stroke and death (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2017.