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Platelet Reactivity and MES During CEA

This study is not yet open for participant recruitment.
Verified March 2012 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Gert Jan de Borst, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01547039
First received: March 2, 2012
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Microembolic signals (MES) [ Time Frame: During and 1 hour following carotid endarterectomy (CEA) ] [ Designated as safety issue: No ]
    Microembolic signals detected by transcranial duplex (TCD)


Secondary Outcome Measures:
  • Ischemic stroke [ Time Frame: within 30 days postoperative ] [ Designated as safety issue: No ]
  • Asymptomatic perioperative myocardial injury [ Time Frame: 3 days postoperative ] [ Designated as safety issue: No ]
    Troponin elevation > 0.1 ng/ml

  • Myocardial infarction [ Time Frame: Within 30 days postoperative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gert Jan de Borst, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01547039     History of Changes
Other Study ID Numbers: NL33061.051.10
Study First Received: March 2, 2012
Last Updated: March 8, 2012
Health Authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)

Keywords provided by UMC Utrecht:
Carotid endarterectomy
Transcranial doppler
Micro embolic signals
Platelets
Aspirin

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

ClinicalTrials.gov processed this record on May 16, 2013