Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis

May 19, 2020 updated by: Tatiana Koudriavtseva, Regina Elena Cancer Institute

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • IRCCS Regina Elena National Cancer Institute
      • Rome, Italy, 00189
        • University of Rome Sapienza
  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Relapsing-remitting multiple sclerosis patients and healthy subjects

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Diagnostic test: Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients
Other Names:
  • 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
Remitting MS patients
Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy.
Diagnostic test: Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients
Other Names:
  • 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
Healthy controls
Age- and sex-matched healthy control subjects.
Diagnostic test: Blood samples and processing
DSC perfusion technique at 3.0-T MRI only in MS patients
Other Names:
  • 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

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
Factor VIII (%)
through study completion, an average of 1 year
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
Factor X (%)
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)
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 (%)
through study completion, an average of 1 year
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
Protein S (%)
through study completion, an average of 1 year
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
Fibrinogen (mg/dl)
through study completion, an average of 1 year
plasma concentration of coagulation factor
Time Frame: through study completion, an average of 1 year
complement (mg/dl)
through study completion, an average of 1 year

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
cerebral blood flow
through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time Frame: through study completion, an average of 1 year
cerebral blood volume
through study completion, an average of 1 year
Brain MRI hemodynamic changes at DSC 3.0-T MRI
Time Frame: through study completion, an average of 1 year
mean transit time
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Collaborators

Icahn School of Medicine at Mount Sinai
University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2017

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

No

Studies a U.S. FDA-regulated device product

No

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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