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NCT01547039 Clinical Trial

Platelet Reactivity and MES During CEA

Myocardial Infarction Clinical Trial

Official title:
Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01547039
Other study ID # NL33061.051.10
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 2, 2012
Last updated March 8, 2012
Start date June 2012
Est. completion date July 2014

Study information
Verified date March 2012
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microembolic signals (MES) Microembolic signals detected by transcranial duplex (TCD) During and 1 hour following carotid endarterectomy (CEA) No
Secondary Ischemic stroke within 30 days postoperative No
Secondary Asymptomatic perioperative myocardial injury Troponin elevation > 0.1 ng/ml 3 days postoperative No
Secondary Myocardial infarction Within 30 days postoperative No
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