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| ID | Type | Description | Link |
|---|---|---|---|
| PE-2013-02357745 | Other Grant/Funding Number | Italian Ministry of Health |
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| Name | Class |
|---|---|
| University of Roma La Sapienza | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapsing MS patients | Patients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy. |
| |
| Remitting MS patients | Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy. |
| |
| Healthy controls | Age- and sex-matched healthy control subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples and processing | Diagnostic Test | DSC perfusion technique at 3.0-T MRI only in MS patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration of coagulation factor | Factor VIII (%) | through study completion, an average of 1 year |
| plasma concentration of coagulation factor | Factor X (%) | through study completion, an average of 1 year |
| plasma concentration of coagulation factor | D-dimer (ng/ml) | through study completion, an average of 1 year |
| plasma concentration of coagulation factor | Protein C (%) | through study completion, an average of 1 year |
| plasma concentration of coagulation factor | Protein S (%) | through study completion, an average of 1 year |
| plasma concentration of coagulation factor | Fibrinogen (mg/dl) | through study completion, an average of 1 year |
| plasma concentration of coagulation factor | complement (mg/dl) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Brain MRI hemodynamic changes at DSC 3.0-T MRI | cerebral blood flow | through study completion, an average of 1 year |
| Brain MRI hemodynamic changes at DSC 3.0-T MRI | cerebral blood volume |
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Inclusion Criteria:
Exclusion Criteria:
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Relapsing-remitting multiple sclerosis patients and healthy subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| IRCCS Regina Elena National Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37583699 | Derived | Koudriavtseva T, Lorenzano S, Cellerino M, Truglio M, Fiorelli M, Lapucci C, D'Agosto G, Conti L, Stefanile A, Zannino S, Filippi MM, Cortese A, Piantadosi C, Maschio M, Maialetti A, Galie E, Salvetti M, Inglese M. Tissue factor as a potential coagulative/vascular marker in relapsing-remitting multiple sclerosis. Front Immunol. 2023 Jul 31;14:1226616. doi: 10.3389/fimmu.2023.1226616. eCollection 2023. | |
| 33193314 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D010314 | Partial Thromboplastin Time |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum/plasma samples
|
| through study completion, an average of 1 year |
| Brain MRI hemodynamic changes at DSC 3.0-T MRI | mean transit time | through study completion, an average of 1 year |
| Rome |
| 00144 |
| Italy |
| University of Rome Sapienza | Rome | 00189 | Italy |
| Derived |
| 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |