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

March 2, 2012
March 8, 2012
June 2012
June 2014   (final data collection date for primary outcome measure)
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)
Microembolic signals (MES) [ Time Frame: During and 1 hour following CEA ] [ Designated as safety issue: No ]
Microembolic signals detected by transcranial duplex (TCD)
Complete list of historical versions of study NCT01547039 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Platelet Reactivity and MES During CEA
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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Probability Sample

patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht

  • Carotid Artery Stenosis
  • Ischemic Stroke
  • Myocardial Infarction
  • Aspirin Resistance
Not Provided
Carotid endarterectomy (CEA)
Patients undergoing carotid endarterectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
July 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Netherlands
 
NCT01547039
NL33061.051.10
No
Gert Jan de Borst, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Gert Jan de Borst, MD, PhD UMC Utrecht
UMC Utrecht
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP