Platelet Reactivity and MES During CEA
This study is not yet open for participant recruitment.
Verified March 2012 by UMC Utrecht
Sponsor:
UMC Utrecht
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 2, 2012 | ||||
| Last Updated Date | March 8, 2012 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) |
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| Original Primary Outcome Measures ICMJE |
Microembolic signals (MES) [ Time Frame: During and 1 hour following CEA ] [ Designated as safety issue: No ] Microembolic signals detected by transcranial duplex (TCD) |
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| Change History | Complete list of historical versions of study NCT01547039 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Platelet Reactivity and MES During CEA | ||||
| Official Title ICMJE | Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy | ||||
| Brief 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). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Plasma |
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| Sampling Method | Probability Sample | ||||
| Study Population | patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Carotid endarterectomy (CEA)
Patients undergoing carotid endarterectomy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | July 2014 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01547039 | ||||
| Other Study ID Numbers ICMJE | NL33061.051.10 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gert Jan de Borst, UMC Utrecht | ||||
| Study Sponsor ICMJE | UMC Utrecht | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | UMC Utrecht | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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