Carotid Artery StenosisNCT01547039
Platelet Reactivity and MES During CEA
An observational study of Carotid Artery Stenosis and Ischemic Stroke, run by UMC Utrecht at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carotid Artery Stenosis, Ischemic Stroke, Myocardial Infarction
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht
Who may be able to join
- Al patients undergoing elective carotid endarterectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
UMC Utrecht
Utrecht, Utrecht, 3584CX
Gert Jan de Borst, MD, PhD, 0031887556965, G.J.deBorst-2@umcutrecht.nl
Gert Jan de Borst, MD, PhD
About this study
Official title: 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).
- Keywords
- Carotid endarterectomy, Transcranial doppler, Micro embolic signals, Platelets, Aspirin
- Medical subject headings
- Carotid Stenosis, Ischemic Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy (CEA) | Patients undergoing carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microembolic signals (MES)
Microembolic signals detected by transcranial duplex (TCD)
Measured: During and 1 hour following carotid endarterectomy (CEA)
Secondary outcomes (3)
Ischemic stroke
Measured: within 30 days postoperative
Asymptomatic perioperative myocardial injury
Troponin elevation > 0.1 ng/ml
Measured: 3 days postoperative
Myocardial infarction
Measured: Within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gert Jan de Borst, UMC Utrecht
- Investigators
- Gert Jan de Borst, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547039
- Sponsor's protocol ID
- NL33061.051.10
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT01547039
- Acronym / sponsor ID
- NL33061.051.10
- Keywords
- Carotid endarterectomy, Transcranial doppler, Micro embolic signals, Platelets, Aspirin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy (CEA) | – | –Patients undergoing carotid endarterectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht
Key inclusion criteria (1 listed)
- Al patients undergoing elective carotid endarterectomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microembolic signals (MES)
Time frame: During and 1 hour following carotid endarterectomy (CEA)
Microembolic signals detected by transcranial duplex (TCD)
3 secondary outcomes
Ischemic stroke
Time frame: within 30 days postoperative
Asymptomatic perioperative myocardial injury
Time frame: 3 days postoperative
Myocardial infarction
Time frame: Within 30 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gert Jan de Borst, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis and Ischemic Stroke, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microembolic signals (MES) (time frame: During and 1 hour following carotid endarterectomy (CEA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.