Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04380220
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2020-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D010314', 'term': 'Partial Thromboplastin Time'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum/plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Factor VIII (%)'}, {'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Factor X (%)'}, {'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'D-dimer (ng/ml)'}, {'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Protein C (%)'}, {'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Protein S (%)'}, {'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Fibrinogen (mg/dl)'}, {'measure': 'plasma concentration of coagulation factor', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'complement (mg/dl)'}], 'secondaryOutcomes': [{'measure': 'Brain MRI hemodynamic changes at DSC 3.0-T MRI', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cerebral blood flow'}, {'measure': 'Brain MRI hemodynamic changes at DSC 3.0-T MRI', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cerebral blood volume'}, {'measure': 'Brain MRI hemodynamic changes at DSC 3.0-T MRI', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'mean transit time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'relapse', 'coagulation', 'complement', 'cerebral blood flow'], 'conditions': ['Multiple Sclerosis', 'Relapse']}, 'referencesModule': {'references': [{'pmid': '37583699', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '33193314', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nPatients 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.\n\nPatients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Relapsing-remitting multiple sclerosis patients and healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT04380220', 'briefTitle': 'Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': '972/17'}, 'secondaryIdInfos': [{'id': 'PE-2013-02357745', 'type': 'OTHER_GRANT', 'domain': 'Italian Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relapsing MS patients', 'description': 'Patients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy.', 'interventionNames': ['Diagnostic Test: Blood samples and processing']}, {'label': 'Remitting MS patients', 'description': 'Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy.', 'interventionNames': ['Diagnostic Test: Blood samples and processing']}, {'label': 'Healthy controls', 'description': 'Age- and sex-matched healthy control subjects.', 'interventionNames': ['Diagnostic Test: Blood samples and processing']}], 'interventions': [{'name': 'Blood samples and processing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['complement C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, aPTT, factor II, v-Willebrand factor, thrombomodulin, Endothelial Protein C Receptor'], 'description': 'DSC perfusion technique at 3.0-T MRI only in MS patients', 'armGroupLabels': ['Healthy controls', 'Relapsing MS patients', 'Remitting MS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'IRCCS Regina Elena National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00189', 'city': 'Rome', 'country': 'Italy', 'facility': 'University of Rome Sapienza', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tatiana Koudriavtseva', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}