NCT04380220

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIAGNOSTIC_TEST	Blood samples and processing	DSC perfusion technique at 3.0-T MRI only in MS patients

Timeline

• Start date: 2017-09-07
• Primary completion: 2020-08-31
• Completion: 2020-12-31
• First posted: 2020-05-08
• Last updated: 2020-05-21

Locations

3 sites across 2 countries: United States, Italy