Platelet Reactivity and MES During CEA

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT01547039

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to analyze the association between aspirin efficacy and general platelet reactivity in relation to microembolic signals (MES) during carotid endarterectomy (CEA).

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis Ischemic Stroke Myocardial Infarction Aspirin Resistance

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Carotid endarterectomy (CEA) Patients undergoing carotid endarterectomy

Outcome Measures

Primary Outcome Measures

Microembolic signals (MES) [During and 1 hour following carotid endarterectomy (CEA)]
Microembolic signals detected by transcranial duplex (TCD)

Secondary Outcome Measures

Ischemic stroke [within 30 days postoperative]
Asymptomatic perioperative myocardial injury [3 days postoperative]
Troponin elevation > 0.1 ng/ml
Myocardial infarction [Within 30 days postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Al patients undergoing elective carotid endarterectomy

Exclusion Criteria:

Patients requiring a blood transfusion prior to surgery
Patients with an inappropriate temporal bone window for transcranial Doppler (TCD)
Patients on vitamin K antagonists or antiplatelet treatment other then aspirin
Patients with an artificial cardiac valve