High-Shear Microfluidic Thrombosis Assay

Emory University16 enrolled

Overview

The purpose of this study is to characterize a new test to assess the rate and time it takes to form a blood clot in people who either do or do not take aspirin.

It is estimated that approximately 25% of people are resistant to aspirin, or do not respond to its effect. These individuals have a four fold higher risk of a heart attack or stroke compared to those who respond to aspirin. Current tests for determining those who are aspirin resistant are not reliable. This study is assessing the effectiveness of a new assay in determining the rate and time it takes for people who are or are not on aspirin in forming a blood clot.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coagulation Defects, Other and Unspecified

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria for "no aspirin" group: * have not taken aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel in the previous 10 days * no history of myocardial infarction, ischemic stroke, or other ischemic event Inclusion Criteria for "aspirin daily" group: * have taken aspirin daily over the last 10 days or more * no history of myocardial infarction, ischemic stroke, or other ischemic event Inclusion Criteria for "new to aspirin" group: * have not previously been prescribed aspirin, but have been prescribed aspirin at their present appointment, e.g. a high calcium plaque score on CT * no history of myocardial infarction, ischemic stroke, or other ischemic event Exclusion Criteria: * a known bleeding or thrombotic disorder Exclusion Criteria for "new to aspirin" group: * a known bleeding or thrombotic disorder * have taken aspirin, other NSAIDs, clopidogrel, or an anticoagulant in the previous 10 days

Locations (1)

Emory Clinic

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Thrombotic occlusion time

A microfluidic assay will be used to assess thrombus formation induced by exposed collagen within a stenosis that induces high shear rates. The amount of time taken to completely occlude an aperture is called the thrombotic occlusion time.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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