Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
2 other identifiers
observational
80
2 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2017
CompletedFirst Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 21, 2020
May 1, 2020
3 years
April 30, 2020
May 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Secondary Outcomes (3)
Brain MRI hemodynamic changes at DSC 3.0-T MRI
through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
through study completion, an average of 1 year
Study Arms (3)
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.
Interventions
DSC perfusion technique at 3.0-T MRI only in MS patients
Eligibility Criteria
Relapsing-remitting multiple sclerosis patients and healthy subjects
You may qualify if:
- patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regina Elena Cancer Institutelead
- University of Roma La Sapienzacollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
Study Sites (3)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
IRCCS Regina Elena National Cancer Institute
Rome, 00144, Italy
University of Rome Sapienza
Rome, 00189, Italy
Related Publications (2)
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: 37583699DERIVEDKoudriavtseva 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.
PMID: 33193314DERIVED
Biospecimen
Serum/plasma samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 8, 2020
Study Start
September 7, 2017
Primary Completion
August 31, 2020
Study Completion
December 31, 2020
Last Updated
May 21, 2020
Record last verified: 2020-05