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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04380220
• Other study ID #: 972/17
• Secondary ID: PE-2013-02357745
• Status: Active, not recruiting
• Start date: September 7, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Recurrence
• Relapse
• Sclerosis

Intervention

Diagnostic Test:
• Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients

Locations

Country	Name	City	State
Italy	IRCCS Regina Elena National Cancer Institute	Rome
Italy	University of Rome Sapienza	Rome
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Icahn School of Medicine at Mount Sinai, University of Roma La Sapienza

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentration of coagulation factor	Factor VIII (%)	through study completion, an average of 1 year
Primary	plasma concentration of coagulation factor	Factor X (%)	through study completion, an average of 1 year
Primary	plasma concentration of coagulation factor	D-dimer (ng/ml)	through study completion, an average of 1 year
Primary	plasma concentration of coagulation factor	Protein C (%)	through study completion, an average of 1 year
Primary	plasma concentration of coagulation factor	Protein S (%)	through study completion, an average of 1 year
Primary	plasma concentration of coagulation factor	Fibrinogen (mg/dl)	through study completion, an average of 1 year
Primary	plasma concentration of coagulation factor	complement (mg/dl)	through study completion, an average of 1 year
Secondary	Brain MRI hemodynamic changes at DSC 3.0-T MRI	cerebral blood flow	through study completion, an average of 1 year
Secondary	Brain MRI hemodynamic changes at DSC 3.0-T MRI	cerebral blood volume	through study completion, an average of 1 year
Secondary	Brain MRI hemodynamic changes at DSC 3.0-T MRI	mean transit time	through study completion, an average of 1 year