Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05773235
Other study ID # 2021-02006
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2024

Study information

Verified date March 2023
Source University Hospital Inselspital, Berne
Contact Marianne Kormann
Phone +41 31 632 70 00
Email studien.stroke@insel.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility For patients with intracerebral hemorrhage Inclusion Criteria: - Patient participating in the PRO-SVD cohort - Symptomatic intracranial hemorrhage - Written informed consent provided by patient or next-of-kin - No contraindications against MRI Exclusion Criteria: - Patient unsuitable for MRI follow-ups (e.g. claustrophobia) - Patients unlikely to attend 1-year follow-up For healthy controls Inclusion Criteria: - Clinically healthy person = 55 years - Written informed consent provided by the healthy control - No contraindications against MRI Exclusion Criteria: - 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.

Study Design


Intervention

Diagnostic Test:
Combined 3- and 7 Tesla-MRI
7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM)

Locations

Country Name City State
Switzerland Department of Neurology, Inselspital Bern University Hospital Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 months
Secondary 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. 24 months
Secondary 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. 24 months
Secondary 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. 24 months
Secondary 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). 24 months
Secondary 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.
24 months
Secondary Functional outcome Modified Rankin Scale (ordinal scale, range 0-6 with 0 corresponding to no symptoms at all and 6 corresponding to death). 24 months
Secondary 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 . 24 months
See also
  Status Clinical Trial Phase
Recruiting NCT05089331 - ROSE-Longitudinal Assessment With Neuroimaging
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT04522102 - Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase Phase 3
Terminated NCT04178746 - PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Not yet recruiting NCT03956485 - Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
Enrolling by invitation NCT02920645 - Multicenter Validation of the AVICH Score N/A
Recruiting NCT02625948 - Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign Phase 2
Completed NCT02478177 - Addressing Real-world Anticoagulant Management Issues in Stroke
Completed NCT01971359 - Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study N/A
Terminated NCT00990509 - Albumin for Intracerebral Hemorrhage Intervention Phase 2
Completed NCT01261091 - Early Tracheostomy in Ventilated Stroke Patients N/A
Completed NCT00716079 - The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial N/A
Recruiting NCT00222625 - rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets Phase 2
Recruiting NCT05095857 - The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury Phase 4
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Not yet recruiting NCT06429332 - International Care Bundle Evaluation in Cerebral Hemorrhage Research Phase 4
Recruiting NCT05492474 - Cranial Ultrasound for Prehospital ICH Diagnosis N/A
Not yet recruiting NCT05502874 - Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Recruiting NCT04604587 - MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA Phase 3
Recruiting NCT05504941 - Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage N/A