Multiple SclerosisNCT03906370
Capillary Dysfunction and CD46-immunoreceptor (CD46) Type in MS
An observational study of Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Diagnostic criteria for MS
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2018to 1 May 2021
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited consecutively on admission for diagnostic investigations to the MS clinic, Department of Neurology, Aarhus University Hospital
Who may be able to join
- Patients > 18 years Patients suspected with MS.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Capillary Dysfunction and CD46 Phenotype in Early Diagnosed MS Patients
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.
Read the detailed description
Multiple sclerosis (MS) is considered a virus-mediated autoimmune disease in the central nerve system characterized by blood brain barrier (BBB) disruption. Conventional magnetic resonance imaging (MRI) is currently an invaluable diagnostic tool as structural lesions are accepted biomarkers. However, MRI lesions correlate poorly with disease burden underlining the clinical-radiological paradox. Therefore, more advanced MRI are needed to provide additional information beyond what is obtainable from conventional scans. Perfusion MRI alterations preceding overt BBB disruption and lesions have been described suggesting a microvascular pathology as an etiological contributor to MS lesions. Transient diffusion decrease observed by diffusion MRI support the hypothesis of a hypoxic event prior to BBB disruption. A new model of perfusion MRI (DSC) enables microvascular function assessment in MS. This model is yet to be tested on MS patients. Furthermore, emerging evidence suggest that virus receptor CD46 affects immunologic susceptibility to MS. CD46 is highly expressed on cerebral vascular endothelium and may protect BBB integrity.
The hypothesis for this project is that CD46 activity is modulator of MS disease development, where CD46 modifications increases vulnerability to BBB disruption by attenuation of normal flow responses in MS brains.
Aims: Besides testing correlations between microvascular dysfunction and MS clinical outcome, this have prompted the investigators to investigate DSC-metric and predicted microvascular dysfunction in relation to defective CD46-driven immune responses.
Method: For this the investigators conducted our MRI study performed in a clinical research setting, and the - immunological study performed in a laboratory setting. Both studies are based on newly diagnosed MS patient assessments conducted at Department of Neurology, Aarhus University Hospital. All subjects undergo clinical examination, blood/cerebrospinal fluid samples and a comprehensive 3Tesla (3T) MRI protocol. MRI parameters and immune responses are compared between study groups and related to clinical outcome.
- Conditions
- Multiple Sclerosis
- Being tested
- Diagnostic criteria for MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic criteria for MSDiagnostic test
The diagnosis healthy/diseased was made by 2017 Mc Donald criteria.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary dysfunction
DSC- metric
Measured: Baseline
CD46 dysfunction
CD46 immune receptor phenotype and function
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Dec 2018
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- 83 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Sundvall, MD, Principal investigator, Department of Neurology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906370
- Sponsor's protocol ID
- MS_CD46_MRI
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Capillary Dysfunction and CD46 Phenotype in Early Diagnosed MS Patients
- ClinicalTrials.gov ID
- NCT03906370
- Acronym / sponsor ID
- MS_CD46_MRI
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 8 Apr 2019 (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 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.
Detailed description
Multiple sclerosis (MS) is considered a virus-mediated autoimmune disease in the central nerve system characterized by blood brain barrier (BBB) disruption. Conventional magnetic resonance imaging (MRI) is currently an invaluable diagnostic tool as structural lesions are accepted biomarkers. However, MRI lesions correlate poorly with disease burden underlining the clinical-radiological paradox. Therefore, more advanced MRI are needed to provide additional information beyond what is obtainable from conventional scans. Perfusion MRI alterations preceding overt BBB disruption and lesions have been described suggesting a microvascular pathology as an etiological contributor to MS lesions. Transient diffusion decrease observed by diffusion MRI support the hypothesis of a hypoxic event prior to BBB disruption. A new model of perfusion MRI (DSC) enables microvascular function assessment in MS. This model is yet to be tested on MS patients. Furthermore, emerging evidence suggest that virus receptor CD46 affects immunologic susceptibility to MS. CD46 is highly expressed on cerebral vascular endothelium and may protect BBB integrity.
The hypothesis for this project is that CD46 activity is modulator of MS disease development, where CD46 modifications increases vulnerability to BBB disruption by attenuation of normal flow responses in MS brains.
Aims: Besides testing correlations between microvascular dysfunction and MS clinical outcome, this have prompted the investigators to investigate DSC-metric and predicted microvascular dysfunction in relation to defective CD46-driven immune responses.
Method: For this the investigators conducted our MRI study performed in a clinical research setting, and the - immunological study performed in a laboratory setting. Both studies are based on newly diagnosed MS patient assessments conducted at Department of Neurology, Aarhus University Hospital. All subjects undergo clinical examination, blood/cerebrospinal fluid samples and a comprehensive 3Tesla (3T) MRI protocol. MRI parameters and immune responses are compared between study groups and related to clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS patients/cases | – | Diagnostic Test: Diagnostic criteria for MSPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited consecutively on admission for diagnostic investigations to the MS clinic, Department of Neurology, Aarhus University Hospital
Key inclusion criteria (1 listed)
- Patients > 18 years Patients suspected with MS.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Diagnostic criteria for MSThe diagnosis healthy/diseased was made by 2017 Mc Donald criteria. | Diagnostic test | MS patients/cases |
Primary outcome
Capillary dysfunction
Time frame: Baseline
DSC- metric
CD46 dysfunction
Time frame: Baseline
CD46 immune receptor phenotype and function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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.
Linda Sundvall, MD principal investigator
Department of Neurology, Aarhus 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 Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 May 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary dysfunction (time frame: Baseline). The study lists 2 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 11 May 2023.