NCT01547039

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

March 2, 2012

Last Update Submit

March 8, 2012

Conditions

Carotid Artery StenosisIschemic StrokeMyocardial InfarctionAspirin Resistance

Keywords

Carotid endarterectomyTranscranial dopplerMicro embolic signalsPlateletsAspirin

Outcome Measures

Primary Outcomes (1)

  • Microembolic signals (MES)

    Microembolic signals detected by transcranial duplex (TCD)

    During and 1 hour following carotid endarterectomy (CEA)

Secondary Outcomes (3)

  • Ischemic stroke

    within 30 days postoperative

  • Asymptomatic perioperative myocardial injury

    3 days postoperative

  • Myocardial infarction

    Within 30 days postoperative

Study Arms (1)

Carotid endarterectomy (CEA)

Patients undergoing carotid endarterectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht

You may qualify if:

  • Al patients undergoing elective carotid endarterectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Carotid StenosisIschemic StrokeMyocardial Infarction

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesStrokeMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Gert Jan de Borst, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

NL(1)