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Platelet Reactivity and MES During CEA

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Gert Jan de Borst, UMC Utrecht.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01547039
First Posted: March 7, 2012
Last Update Posted: March 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gert Jan de Borst, UMC Utrecht
  Purpose
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
Carotid Artery Stenosis Ischemic Stroke Myocardial Infarction Aspirin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy

Further study details as provided by Gert Jan de Borst, UMC Utrecht:

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


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

  • Myocardial infarction [ Time Frame: Within 30 days postoperative ]

Biospecimen Retention:   Samples Without DNA
Plasma

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Carotid endarterectomy (CEA)
Patients undergoing carotid endarterectomy

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
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


Locations
Netherlands
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
Investigators
Principal Investigator: Gert Jan de Borst, MD, PhD UMC Utrecht
  More Information

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 Submitted: March 2, 2012
First Posted: March 7, 2012
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
Platelets
Aspirin

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