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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04380220

Enrollment

Registered

2020-05-08

Start date

2017-09-07

Completion date

2020-12-31

Last updated

2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapse

Keywords

multiple sclerosis, relapse, coagulation, complement, cerebral blood flow

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.

Interventions

DIAGNOSTIC_TESTBlood samples and processing

DSC perfusion technique at 3.0-T MRI only in MS patients

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
plasma concentration of coagulation factor	through study completion, an average of 1 year	Factor VIII (%)

Secondary

Measure	Time frame	Description
Brain MRI hemodynamic changes at DSC 3.0-T MRI	through study completion, an average of 1 year	cerebral blood flow

Countries

Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026