Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-07

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC.

Patients and controls will be tested for either coagulation/complement (C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, factor II, aPTT, von-Willebrand factor), soluble markers of endothelial damage (thrombomodulin, Endothelial Protein C Receptor), antiphospholipid antibodies, lupus anticoagulant, complete blood count, viral serological assays or microRNA microarray.

Patients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Coagulation in Multiple Sclerosis

NCT01711255

Multiple Sclerosis

COMPLETED

Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis

NCT04201470

Relapsing Remitting Multiple Sclerosis Progressive Multiple Sclerosis Controls +1 more

COMPLETED NA

Role of Microglia in the Pathogenesis of Progressive Multiple Sclerosis

NCT03134716

Multiple Sclerosis

ACTIVE_NOT_RECRUITING

Observational Trial Evaluating Elevated Factor VIII Related Labs as a Biomarker for Incomplete Relapse Recovery

NCT05926167

Multiple Sclerosis Relapse

UNKNOWN

Venous Irregularities, Flow and Perfusion in MS Study

NCT01593904

Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Relapsing MS patients

Patients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy.

Blood samples and processing

Intervention Type DIAGNOSTIC_TEST

DSC perfusion technique at 3.0-T MRI only in MS patients

Remitting MS patients

Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy.

Blood samples and processing

Intervention Type DIAGNOSTIC_TEST

DSC perfusion technique at 3.0-T MRI only in MS patients

Healthy controls

Age- and sex-matched healthy control subjects.

Blood samples and processing

Intervention Type DIAGNOSTIC_TEST

DSC perfusion technique at 3.0-T MRI only in MS patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood samples and processing

DSC perfusion technique at 3.0-T MRI only in MS patients

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

complement C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, aPTT, factor II, v-Willebrand factor, thrombomodulin, Endothelial Protein C Receptor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission

Exclusion Criteria

* pregnant, with any neoplastic, hematologic, thyroid, metabolic, thrombotic or autoimmune disease, drug or alcohol addicted, treated with immunosuppressive drugs, steroids o any medication interfering with coagulation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes