Multiple Sclerosis Clinical Trial
Official title:
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Verified date | May 2020 |
Source | Regina Elena Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Regina Elena Cancer Institute | Icahn School of Medicine at Mount Sinai, University of Roma La Sapienza |
United States, Italy,
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 |
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