Platelet Reactivity and MES During CEA | NCT01547039

Studies
Platelet Reactivity and MES During CEA

NCT01547039

Sponsor

UMC Utrecht

Status

Unknown status

Last Update Posted

Mar 12, 2012Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Carotid Artery Stenosis
Ischemic Stroke
Myocardial Infarction
Aspirin Resistance

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Mar 2, 2012

First Submission Date that Met QC Criteria

Mar 2, 2012

First Posted Date

Mar 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2012

Last Update Posted Date

Mar 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carotid endarterectomy (CEA)		Patients undergoing carotid endarterectomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microembolic signals (MES)	Microembolic signals detected by transcranial duplex (TCD)	During and 1 hour following carotid endarterectomy (CEA)

Secondary Outcomes

Measure	Description	Time Frame
Ischemic stroke		within 30 days postoperative
Asymptomatic perioperative myocardial injury	Troponin elevation > 0.1 ng/ml	3 days postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gert Jan de Borst, MD, PhD	UMC Utrecht	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC Utrecht		Utrecht	Utrecht	3584CX	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D016893	Carotid Stenosis
D000083242	Ischemic Stroke
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided