Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
NCT04380220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80
Last updated 2020-05-21
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.
Conditions
- Multiple Sclerosis
- Relapse
Interventions
- DIAGNOSTIC_TEST
-
Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients
Sponsors & Collaborators
-
University of Roma La Sapienza
collaborator OTHER -
Icahn School of Medicine at Mount Sinai
collaborator OTHER -
Regina Elena Cancer Institute
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-07
- Primary Completion
- 2020-08-31
- Completion
- 2020-12-31
Countries
- United States
- Italy
Study Locations
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