PRO-SVD: Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05734378
• Collaborator: (none)
• Enrollment: 900
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Amyloid Angiopathy; Small Vessel Cerebrovascular Disease; Cadasil; CAA - Cerebral Amyloid Angiopathy

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 900 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Nov 30, 2030
• Anticipated Study Completion Date: Nov 30, 2030

Outcome Measures

Primary Outcome Measures

1. Intracerebral haemorrhage (ICH) [1 year]

   Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)

2. Ischaemic stroke [1 year]

3. Cardio-vascular death [1 year]

Secondary Outcome Measures

1. Other intracranial bleeding [1 year]

   Subdural haematoma, subarachnoid haemorrhage

2. Other (transient) neurological attacks [1 year]

   Including transient ischaemic attack (TIA), transient neurological attack (TNA), amyloid spells, (focal) seizures

3. Cognitive impairment [1 year]

4. New-onset of extracranial vascular disease [1 year]

5. Functional outcome [1 year]

   Modified Rankin scale score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Life expectancy of <6 months due to not-SVD related causes (i.e. cancer)

• Patient is unlikely to attend follow-up visits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Inselspital Bern University Hospital	Bern		Switzerland	3010

Sponsors and Collaborators

• University Hospital Inselspital, Berne

Investigators

• Principal Investigator: David J Seiffge, Prof, MD, Department of Neurology, Inselspital Bern University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT05734378
• Other Study ID Numbers: 2020-02535
• First Posted: Feb 17, 2023
• Last Update Posted: Feb 17, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Inselspital, Berne: small vessel disease; CAA; cerebral amyloid angiopathy; hypertensive arteriopathy; deep perforator arteriopathy; CADASIL
• Additional relevant MeSH terms: Cerebrovascular Disorders; Cerebral Small Vessel Diseases; Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; CADASIL; Dementia, Multi-Infarct; Amyloidosis

Study Results

No Results Posted as of Feb 17, 2023