Intracerebral HemorrhageMRI-PRO-SVDNCT05773235
MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events
An observational study of Intracerebral Hemorrhage and CAA - Cerebral Amyloid Angiopathy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracerebral Hemorrhage, CAA - Cerebral Amyloid Angiopathy, Cerebral Small Vessel Diseases
- What is being tested?
- Combined 3- and 7 Tesla-MRI
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2022to 30 Jun 2024
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 50 consecutive patients with cerebral small vessel disease-related intracerebral hemorrhage admitted to the Inselspital Bern. Patients will undergo combined 3/7 Tesla-MRI according to a standardised small vessel disease MRI protocol at 3 timepoints. A control group consisting of 10 clinically asymptomatic subjects will undergo the same MRI protocol at one timepoint.
Who may be able to join
- Patient participating in the PRO-SVD cohort
- Symptomatic intracranial hemorrhage
- Written informed consent provided by patient or next-of-kin
- No contraindications against MRI
- Clinically healthy person ≥ 55 years
- Written informed consent provided by the healthy control
- No contraindications against MRI
Who cannot join
- Patient unsuitable for MRI follow-ups (e.g. claustrophobia)
- Patients unlikely to attend 1-year follow-up
- For healthy controls
- Known or suspected cerebral small vessel diseases or presence of concurrent diseases potentially mimicking small vessel disease (e.g. multiple sclerosis, previous heart surgery etc.)
- Pre-existing dementia, cognitive decline or disorder of the central nervous system.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neurology, Inselspital Bern University Hospital
Bern, 3010
David J Seiffge, MD, Prof, +41 31 632 70 00, david.seiffge@insel.ch
Martina B Goeldlin, MD
About this study
Official title: MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events - a Prospective Cohort Study
This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.
- Conditions
- Intracerebral Hemorrhage, CAA - Cerebral Amyloid Angiopathy, Cerebral Small Vessel Diseases
- Being tested
- Combined 3- and 7 Tesla-MRI
- Keywords
- Intracerebral hemorrhage, Ischemic stroke, Cerebral amyloid angiopathy, Hypertensive deep perforator arteriopathy, 7 Tesla-MRI, Cerebral small vessel disease, Ultra high-field MRI
- Medical subject headings
- Cerebral Hemorrhage, Cerebral Amyloid Angiopathy, Familial, Cerebral Small Vessel Diseases, Ischemic Stroke, Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined 3- and 7 Tesla-MRIDiagnostic test
7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM)
| Study group | Role | What they receive |
|---|---|---|
| Patients with intracerebral hemorrhage | Patients with symptomatic intracranial hemorrhage (defined as non-traumatic intracerebral hemorrhage or convexity, non-aneurysmal subarachnoid hemorrhage) enrolled in the PRO-SVD study Receives: Diagnostic Test: Combined 3- and 7 Tesla-MRI | |
| Healthy controls | Clinically healthy persons of at least 55 years of age Receives: Diagnostic Test: Combined 3- and 7 Tesla-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Composite endpoint of a new, clinically symptomatic ischaemic or haemorrhagic event as defined by the treating physician and/or any increase in small vessel disease and/or cerebral amyloid angiopathy burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.
Measured: 24 months
Secondary outcomes (7)
MRI-defined disease progression
Any increase in small vessel disease (SVD) and/or cerebral amyloid angiopathy (CAA) burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.
Measured: 24 months
Increase in number of SVD-attributable, ischaemic lesions
Composite outcome defined as any increase in numeric count for lacunes and/or increase in perivascular space severity scale (0/1-10 PVS/11-20 PVS/21-40 PVS/>40 PVS) and/or increase in periventricular or deep separate white matter Fazekas scale.
Measured: 24 months
Increase in number of SVD-attributable, haemorrhagic lesions
Composite outcome defined as any increase in numeric count for cerebral microbleeds and/or increase in cortical superficial siderosis multifocality score.
Measured: 24 months
Increase in perivascular space severity scale
Defined as any increase in perivascular space (PVS) severity scale (0/1-10 PVS/11-20 PVS/21-40 PVS/>40 PVS, higher number of PVS means higher small vessel disease burden).
Measured: 24 months
Clinical, vascular outcome event
Composite endpoint including any of the following, clinically apparent events:
- ischaemic stroke as diagnosed by CT or MRI and causing a corresponding clinical deficit (as assessed by the treating physician)
- intracerebral haemorrhage as diagnosed by CT or MRI and causing a corresponding clinical deficit (as assessed by the treating physician)
- systemic vascular event defined as radiological or clinical evidence of arterial hypoperfusion and judged by the treating physician to be due to an atherosclerotic or embolic cause.
Measured: 24 months
Functional outcome
Modified Rankin Scale (ordinal scale, range 0-6 with 0 corresponding to no symptoms at all and 6 corresponding to death).
Measured: 24 months
New cognitive impairment
Montreal Cognitive Assessment (MoCA, range 0-30 points) < 26 points (corresponding to impaired cognitive function) and/or new impairment in activities of daily living as defined by the treating physician .
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Seiffge, Prof, MD, Principal investigator, Department of Neurology, Inselspital Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773235
- Sponsor's protocol ID
- 2021-02006
- Acronym
- MRI-PRO-SVD
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing can be discussed by qualified researchers with the principal investigator upon reasonable request and might be subject to prior additional approval by the respective ethical board.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05773235
- Acronym / sponsor ID
- MRI-PRO-SVD / 2021-02006
- Conditions
- Intracerebral Hemorrhage, CAA - Cerebral Amyloid Angiopathy, Cerebral Small Vessel Diseases
- Keywords
- Intracerebral hemorrhage, Ischemic stroke, Cerebral amyloid angiopathy, Hypertensive deep perforator arteriopathy, 7 Tesla-MRI, Cerebral small vessel disease, Ultra high-field MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Mar 2023 (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.
This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with intracerebral hemorrhage | – | Diagnostic Test: Combined 3- and 7 Tesla-MRIPatients with symptomatic intracranial hemorrhage (defined as non-traumatic intracerebral hemorrhage or convexity, non-aneurysmal subarachnoid hemorrhage) enrolled in the PRO-SVD study |
| Healthy controls | – | Diagnostic Test: Combined 3- and 7 Tesla-MRIClinically healthy persons of at least 55 years of age |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 consecutive patients with cerebral small vessel disease-related intracerebral hemorrhage admitted to the Inselspital Bern. Patients will undergo combined 3/7 Tesla-MRI according to a standardised small vessel disease MRI protocol at 3 timepoints. A control group consisting of 10 clinically asymptomatic subjects will undergo the same MRI protocol at one timepoint.
Key inclusion criteria (7 listed)
- Patient participating in the PRO-SVD cohort
- Symptomatic intracranial hemorrhage
- Written informed consent provided by patient or next-of-kin
- No contraindications against MRI
- Clinically healthy person ≥ 55 years
Key exclusion criteria (5 listed)
- Patient unsuitable for MRI follow-ups (e.g. claustrophobia)
- Patients unlikely to attend 1-year follow-up
- For healthy controls
- Known or suspected cerebral small vessel diseases or presence of concurrent diseases potentially mimicking small vessel disease (e.g. multiple sclerosis, previous heart surgery etc.)
- Pre-existing dementia, cognitive decline or disorder of the central nervous system.
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 |
|---|---|---|
| Combined 3- and 7 Tesla-MRI7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM) | Diagnostic test | Healthy controls, Patients with intracerebral hemorrhage |
Primary outcome
Disease progression
Time frame: 24 months
Composite endpoint of a new, clinically symptomatic ischaemic or haemorrhagic event as defined by the treating physician and/or any increase in small vessel disease and/or cerebral amyloid angiopathy burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.
7 secondary outcomes
MRI-defined disease progression
Time frame: 24 months
Increase in number of SVD-attributable, ischaemic lesions
Time frame: 24 months
Increase in number of SVD-attributable, haemorrhagic lesions
Time frame: 24 months
Increase in perivascular space severity scale
Time frame: 24 months
Clinical, vascular outcome event
Time frame: 24 months
Functional outcome
Time frame: 24 months
New cognitive impairment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Yes. Data sharing can be discussed by qualified researchers with the principal investigator upon reasonable request and might be subject to prior additional approval by the respective ethical board.
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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.
David J Seiffge, Prof, MD principal investigator
Department of Neurology, Inselspital Bern University Hospital
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 CAA - Cerebral Amyloid Angiopathy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 5 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 17 Mar 2023. 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 Switzerland. 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?
Contact Marianne Kormann (+41 31 632 70 00, studien.stroke@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression (time frame: 24 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 17 Mar 2023.