Clinical trial NCT04380220: Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Official title: Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Relapse
Keywords: multiple sclerosis
relapse
coagulation
complement
cerebral blood flow
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: Icahn School of Medicine at Mount Sinai
First posted: 2020-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsing-remitting multiple sclerosis patients and healthy subjects

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.


Eligibility criteria: 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.

Primary outcomes:
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
measure: plasma concentration of coagulation factor
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Brain MRI hemodynamic changes at DSC 3.0-T MRI
timeFrame: through study completion, an average of 1 year
measure: Brain MRI hemodynamic changes at DSC 3.0-T MRI
timeFrame: through study completion, an average of 1 year
measure: Brain MRI hemodynamic changes at DSC 3.0-T MRI
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rome
country: Italy
facility: IRCCS Regina Elena National Cancer Institute
city: Rome
country: Italy
facility: University of Rome Sapienza
Study officials:
References:
citation: Koudriavtseva T, Stefanile A, Fiorelli M, Lapucci C, Lorenzano S, Zannino S, Conti L, D'Agosto G, Pimpinelli F, Di Domenico EG, Mandoj C, Giannarelli D, Donzelli S, Blandino G, Salvetti M, Inglese M. Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-Remitting Multiple Sclerosis. Front Immunol. 2020 Oct 27;11:548604. doi: 10.3389/fimmu.2020.548604. eCollection 2020.