Evaluation of Coagulation in Multiple Sclerosis

Study Overview
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Brief Summary
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Recent research in multiple sclerosis (MS) have suggested that altered coagulation and vascular inflammation may play a role in pathophysiology of MS. Sonoclot is viscoelastic method of analyzing clot formation. This instrument will be used to compare coagulation in individuals with MS to healthy controls. A 24-hour dietary recall and food frequency questionnaire will help determine whether coagulation is modified by fish consumption.

Detailed Description
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This case-control study will recruit individuals with a diagnosis of MS and healthy controls. Individuals will be asked to come to Bastyr Clinical Research Center for a single study visit, at which time dietary intake, current medications and supplements, other medical diagnoses, and coagulation will be evaluated.

Official Title
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A Cross-Sectional Study of Coagulation in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of clinically probable of clinically definite multiple sclerosis made by board certified neurologist. Subject must be willing to release medical information regarding diagnosis Controls must consider themselves healthy and be free of any neurological, autoimmune, endocrine or other chronic disease. Must also be free of any recent acute illness/injury that can influence inflammatory activity. Individuals must be 18 or older Exclusion Criteria: Diagnosis of coagulation defect Use of anticoagulants (eg. warfarin, coumadin) or Aspirin within 30 days of entry. NSAID within 7 days of entry (dietary intake of fish oil or tumeric is acceptable) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis<br>Subjects who have been diagnosed with clinically definite or probable multiple sclerosis as defined and recorded by board certified neurologist. | |
| Healthy controls<br>Adults age 18 and older who have not been diagnosed with any neurological, endocrine, or other chronic health condition. They must also be free of any recent acute illness that can impact inflammation/clotting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sonoclot Coagulation Spectrum (Sonoclot Signature) | The Sonoclot Coagulation Spectrum represents a combination of coagulation parameters, including activated clotting time, clot rate, time to peak, and peak amplitude. The mean value of all contributing parameters will be compared between cases and controls. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASA24 omega-3 fatty acid intake | The ASA24, in combination with a medication history, will be used to evaluate whether omega-3 fatty acid intake is associated with reduced rates of coagulation in either cases or controls. | 24 hour recall (24 hours prior to study visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Coagulation, Alternative Medicine, Clotting, Complementary Medicine, Inflammation