Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Status unconfirmed
Conditions studied: Multiple Sclerosis, Relapse
In brief
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.
Key facts
- Study ID
- NCT04380220
- Run by
- Regina Elena Cancer Institute
- People needed
- 80
- Starts
- 2017-09-07
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2020-05-21
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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