Capillary Dysfunction and CD46-immunoreceptor (CD46) Type in MS

NCT03906370 | Completed DMC

• 1 other identifier: MS_CD46_MRI
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to contribute knowledge to early MS disease mechanisms at the brain-blood interface using a combined immunological and neuroimaging approach. The aim is to provide a novel vascular model to assess MS disease activity, and to explore its potential as an early diagnostic biomarker, prior to blood-brain barrier disruption. Additionally, the investigators want to investigate influence of immune receptor defects upon disease activity and MS brain vascular system. These aims are addressed by investigating immune receptor signals and vascular imaging modalities acquired in newly diagnosed untreated MS cohort, followed at our institution.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Capillary dysfunction

  DSC- metric

  Baseline

• CD46 dysfunction

  CD46 immune receptor phenotype and function

  Baseline

Study Arms (2)

MS patients/cases

Patients admitted for diagnostic investigations to the MS clinic were offered participation if aged \>18 years and no previous use of immunosuppressing or modifying drugs within 6 months. The diagnosis healthy/diseased was made by 2017 Mc Donald criteria.

Diagnostic Test: Diagnostic criteria for MS

Healthy subjects/controls

Patients admitted for diagnostic investigations to the MS clinic were offered participation if aged \>18 years and no previous use of immunosuppressing or modifying drugs within 6 months. The diagnosis healthy/diseased was made by 2017 Mc Donald criteria.

Interventions

Diagnostic criteria for MS DIAGNOSTIC_TEST

The diagnosis healthy/diseased was made by 2017 Mc Donald criteria.

MS patients/cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited consecutively on admission for diagnostic investigations to the MS clinic, Department of Neurology, Aarhus University Hospital

You may qualify if:

• Patients \> 18 years Patients suspected with MS.

You may not qualify if:

• Pregnancy. Drug/alcohol abuse. Cerebral tumor. Previous head injury. Previous use of immunosuppressing or modifying treatment within 6 months. Contraindications against contrast media. Baseline image analysis not available.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Neurology

Aarhus, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and Spinal fluid samples

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Linda Sundvall, MD

  Department of Neurology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Study Start: December 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 11, 2023

Record last verified: 2019-04

Locations

DK (1)