Platelet Reactivity and MES During CEA
March 8, 2012 updated by: Gert Jan de Borst, UMC Utrecht
Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy
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).
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utrecht, Netherlands, 3584CX
- UMC Utrecht
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Carotid endarterectomy (CEA)
Patients undergoing carotid endarterectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microembolic signals (MES)
Time Frame: During and 1 hour following carotid endarterectomy (CEA)
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Microembolic signals detected by transcranial duplex (TCD)
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During and 1 hour following carotid endarterectomy (CEA)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ischemic stroke
Time Frame: within 30 days postoperative
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within 30 days postoperative
|
|
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Asymptomatic perioperative myocardial injury
Time Frame: 3 days postoperative
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Troponin elevation > 0.1 ng/ml
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3 days postoperative
|
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Myocardial infarction
Time Frame: Within 30 days postoperative
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Within 30 days postoperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
March 2, 2012
First Submitted That Met QC Criteria
March 2, 2012
First Posted (Estimate)
March 7, 2012
Study Record Updates
Last Update Posted (Estimate)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 8, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Carotid Artery Diseases
- Stroke
- Myocardial Infarction
- Infarction
- Ischemic Stroke
- Carotid Stenosis
Other Study ID Numbers
- NL33061.051.10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.