Cerebral Amyloid AngiopathyPRO-SVDNCT05734378
Prognosis of Cerebral Small Vessel Disease
An observational study of Cerebral Amyloid Angiopathy and Small Vessel Cerebrovascular Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation. The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease, Cadasil
- How many people
- 900 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2020to 30 Nov 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Child, Adult, Older adult
Study population: This is a prospectively recruited cohort of patients treated with cerebral small vessel disease at Inselspital Bern University Hospital. Patients are recruited at the emergency department, neurology in-patient ward, Stroke Unit, IMC, ICU and outpatient clinics.
Who may be able to join
- Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II)
- Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2)
- Other SVD (i.e. CADASIL or other sporadic or genetic SVD)
Who cannot join
- Life expectancy of <6 months due to not-SVD related causes (i.e. cancer)
- Patient is unlikely to attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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: Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation.
The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.
- Conditions
- Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease, Cadasil, CAA - Cerebral Amyloid Angiopathy
- Keywords
- small vessel disease, CAA, cerebral amyloid angiopathy, hypertensive arteriopathy, deep perforator arteriopathy, CADASIL
- Medical subject headings
- Cerebral Amyloid Angiopathy, Cerebral Small Vessel Diseases, CADASIL, Cerebral Amyloid Angiopathy, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracerebral haemorrhage (ICH)
Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)
Measured: 1 year
Ischaemic stroke
Defined by CT and/or MRI
Measured: 1 year
Cardio-vascular death
According to the treating physician
Measured: 1 year
Secondary outcomes (5)
Other intracranial bleeding
Subdural haematoma, subarachnoid haemorrhage
Measured: 1 year
Other (transient) neurological attacks
Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures
Measured: 1 year
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: 1 year
New-onset of extracranial vascular disease
As judged by the treating physician
Measured: 1 year
Functional outcome
Modified Rankin scale score (ordinal score, range 0-6, a score of 0 corresponds to no symptoms at all, while a score of 6 corresponds to death)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Dec 2020
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Amyloid AngiopathyStudies 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
- 900 participants (estimated)
- Target duration
- 1 Year
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
- NCT05734378
- Sponsor's protocol ID
- 2020-02535
- Acronym
- PRO-SVD
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
- ClinicalTrials.gov ID
- NCT05734378
- Acronym / sponsor ID
- PRO-SVD / 2020-02535
- Conditions
- Cerebral Amyloid Angiopathy, Small Vessel Cerebrovascular Disease, Cadasil, CAA - Cerebral Amyloid Angiopathy
- Keywords
- small vessel disease, CAA, cerebral amyloid angiopathy, hypertensive arteriopathy, deep perforator arteriopathy, CADASIL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 17 Feb 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.
Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation.
The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospectively recruited cohort of patients treated with cerebral small vessel disease at Inselspital Bern University Hospital. Patients are recruited at the emergency department, neurology in-patient ward, Stroke Unit, IMC, ICU and outpatient clinics.
Key inclusion criteria (3 listed)
- Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II)
- Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2)
- Other SVD (i.e. CADASIL or other sporadic or genetic SVD)
Key exclusion criteria (2 listed)
- Life expectancy of <6 months due to not-SVD related causes (i.e. cancer)
- Patient is unlikely to attend follow-up visits
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
Intracerebral haemorrhage (ICH)
Time frame: 1 year
Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)
Ischaemic stroke
Time frame: 1 year
Defined by CT and/or MRI
Cardio-vascular death
Time frame: 1 year
According to the treating physician
5 secondary outcomes
Other intracranial bleeding
Time frame: 1 year
Other (transient) neurological attacks
Time frame: 1 year
Cognitive impairment
Time frame: 1 year
New-onset of extracranial vascular disease
Time frame: 1 year
Functional outcome
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Amyloid Angiopathy
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A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy
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Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
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Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.
Cerebral Amyloid Angiopathy, CAA - Cerebral Amyloid Angiopathy
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Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)
Stroke, Moyamoya Disease
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of NPI-001 in Patients With Hereditary Cystatin C Amyloid Angiopathy (HCCAA)
Hereditary Cystatin C Amyloid Angiopathy (HCCAA), Hemorrhage Brain
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.
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 Cerebral Amyloid Angiopathy and Small Vessel Cerebrovascular Disease, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 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?
This study is still under way. Results are not available in the source record yet.
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?
Intracerebral haemorrhage (ICH) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 8 Mar 2023.