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Platelet Reactivity and MES During CEA

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by UMC Utrecht.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Carotid Artery Diseases
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014