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Platelet Reactivity and MES During CEA

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ClinicalTrials.gov Identifier: NCT01547039
Recruitment Status : Unknown
Verified March 2012 by Gert Jan de Borst, UMC Utrecht.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2012
Last Update Posted : March 12, 2012
Information provided by (Responsible Party):
Gert Jan de Borst, UMC Utrecht

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
Carotid Artery Stenosis Ischemic Stroke Myocardial Infarction Aspirin Resistance

Study Type : Observational
Estimated 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 : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014

Carotid endarterectomy (CEA)
Patients undergoing carotid endarterectomy

Primary Outcome Measures :
  1. Microembolic signals (MES) [ Time Frame: During and 1 hour following carotid endarterectomy (CEA) ]
    Microembolic signals detected by transcranial duplex (TCD)

Secondary Outcome Measures :
  1. Ischemic stroke [ Time Frame: within 30 days postoperative ]
  2. Asymptomatic perioperative myocardial injury [ Time Frame: 3 days postoperative ]
    Troponin elevation > 0.1 ng/ml

  3. Myocardial infarction [ Time Frame: Within 30 days postoperative ]

Biospecimen Retention:   Samples Without DNA

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547039

UMC Utrecht Not yet recruiting
Utrecht, Netherlands, 3584CX
Contact: Gert Jan de Borst, MD, PhD    0031887556965    G.J.deBorst-2@umcutrecht.nl   
Principal Investigator: Gert Jan de Borst, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: Gert Jan de Borst, MD, PhD UMC Utrecht

Responsible Party: Gert Jan de Borst, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01547039     History of Changes
Other Study ID Numbers: NL33061.051.10
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Gert Jan de Borst, UMC Utrecht:
Carotid endarterectomy
Transcranial doppler
Micro embolic signals

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases