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

Conditions
Relapse
Multiple Sclerosis
Registration Number
NCT04380220
Lead Sponsor
Regina Elena Cancer Institute
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
plasma concentration of coagulation factorthrough study completion, an average of 1 year

complement (mg/dl)

Secondary Outcome Measures
NameTimeMethod
Brain MRI hemodynamic changes at DSC 3.0-T MRIthrough study completion, an average of 1 year

mean transit time

Trial Locations

Locations (3)

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

IRCCS Regina Elena National Cancer Institute

🇮🇹

Rome, Italy

University of Rome Sapienza

🇮🇹

Rome, Italy

Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States

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