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

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

      • Utrecht, Netherlands, 3584CX
        • UMC Utrecht
        • Contact:
        • Principal Investigator:
          • Gert Jan de Borst, MD, PhD

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: within 30 days postoperative
within 30 days postoperative
Asymptomatic perioperative myocardial injury
Time Frame: 3 days postoperative
Troponin elevation > 0.1 ng/ml
3 days postoperative
Myocardial infarction
Time Frame: Within 30 days postoperative
Within 30 days postoperative

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

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.

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