- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04380220
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rome, Italy, 00144
- IRCCS Regina Elena National Cancer Institute
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Rome, Italy, 00189
- University of Rome Sapienza
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Relapsing MS patients
Patients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy.
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DSC perfusion technique at 3.0-T MRI only in MS patients
Other Names:
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Remitting MS patients
Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy.
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DSC perfusion technique at 3.0-T MRI only in MS patients
Other Names:
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Healthy controls
Age- and sex-matched healthy control subjects.
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DSC perfusion technique at 3.0-T MRI only in MS patients
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
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Factor VIII (%)
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through study completion, an average of 1 year
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plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
|
Factor X (%)
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through study completion, an average of 1 year
|
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
|
D-dimer (ng/ml)
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through study completion, an average of 1 year
|
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
|
Protein C (%)
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through study completion, an average of 1 year
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plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
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Protein S (%)
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through study completion, an average of 1 year
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plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
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Fibrinogen (mg/dl)
|
through study completion, an average of 1 year
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plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
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complement (mg/dl)
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time Frame: through study completion, an average of 1 year
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cerebral blood flow
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through study completion, an average of 1 year
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Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time Frame: through study completion, an average of 1 year
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cerebral blood volume
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through study completion, an average of 1 year
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Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time Frame: through study completion, an average of 1 year
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mean transit time
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through study completion, an average of 1 year
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Disease Attributes
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Recurrence
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Immunologic Factors
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Anticoagulants
- Coagulants
- Factor VIII
- Antithrombins
- Protein C
- Protein S
- Complement C3
Other Study ID Numbers
- 972/17
- PE-2013-02357745 (Other Grant/Funding Number: Italian Ministry of Health)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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