Evaluation of Coagulation in Multiple Sclerosis

NCT01711255 | Completed

• 1 other identifier: BU-12A-1323
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Coagulation; Alternative Medicine; Clotting; Complementary Medicine; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ASA24 omega-3 fatty acid intake

  24 hour recall (24 hours prior to study visit)

Study Arms (2)

Multiple Sclerosis

Subjects who have been diagnosed with clinically definite or probable multiple sclerosis as defined and recorded by board certified neurologist.

Healthy controls

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be sixty (60) individuals with diagnosed or probable multiple sclerosis, verified by board certified neurologist, and forty (40) age and sex matched healthy controls.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bastyr University: lead

Study Sites (1)

Bastyr University Clinical Research Center

Kenmore, Washington, 98028, United States

Location

Related Links

• Related info

Biospecimen

Retention: SAMPLES WITH DNA

Six (6) whole blood vials of 10ml each will be collected from each subject. Three (3) will be stored for future use. Three will be used immediately for coagulation analysis using Sonoclot.

MeSH Terms

Conditions

Multiple Sclerosis; Thrombosis; Inflammation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurie K Mischley, ND

  Bastyr University - Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

US (1)