Carotid Artery StenosesNCT04029259
Pre- and Post-operative Brain MRI in Carotid Endarterectomy
An observational study of Carotid Artery Stenoses, run by Oslo University Hospital.
Trial summary
Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Artery Stenoses
- What is being tested?
- Brain MRI
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 31 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to the Department of Vascular Surgery at Oslo University Hospital for carotid endarterectomy. International guidelines on indications for surgery are followed, and the majority of the patients have symptomatic carotid stenosis occluding > 70% of the lumen of the internal carotid artery. Patients characteristics and indications for surgery are registered
Who may be able to join
- Indication for carotid surgery
Who cannot join
- Contraindications to MRI
About this study
Official title: Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy
Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI.
Read the detailed description
Patients undergoing surgery for carotid stenosis in our Department are examined by brain MRI before and after carotid surgery to evaluate the rationale for the MRI. Brain lesions on MRI before and after carotid surgery are registered, and related to clinical findings. The purpose of the study is to evaluate whether brain MRI in relation to carotid endarterectomy gives additional information to clinical findings, and to CT scan of the brain.
- Conditions
- Carotid Artery Stenoses
- Being tested
- Brain MRI
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDiagnostic test
Brain MRI diagnoses tromboembolic lesions or bleeding to the cerebrum and is part of preoperative diagnostic tests before carotid surgery. After surgery brain MRI may present New lesions related to surgery, clinically significant or insignificant. Our goal is to evaluate the relevance of this modality in carotid surgery..
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain lesions on MRI
Lesions on brain MRI representing thromboembolic or hemorrhagic episodes
Measured: 30 days
Secondary outcomes (1)
Time from Transient Ischemic Attack (TIA) or minor stroke to surgery
International guidelines recommends surgery within 14 days after TIA
Measured: Days before surgery, maximum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Jan 2005
- Primary completion31 Dec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toril Rabben, Oslo University Hospital
- Investigators
- Toril Rabben, PhD, Principal investigator, Oslo University Hospital, Dep. of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029259
- Sponsor's protocol ID
- MR caput and CEA
- Status last verified
- Jul 2019
- First submitted
- 3 Aug 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT04029259
- Acronym / sponsor ID
- MR caput and CEA
- Conditions
- Carotid Artery Stenoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Jul 2019 (actual)
- 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.
Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI.
Detailed description
Patients undergoing surgery for carotid stenosis in our Department are examined by brain MRI before and after carotid surgery to evaluate the rationale for the MRI. Brain lesions on MRI before and after carotid surgery are registered, and related to clinical findings. The purpose of the study is to evaluate whether brain MRI in relation to carotid endarterectomy gives additional information to clinical findings, and to CT scan of the brain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the Department of Vascular Surgery at Oslo University Hospital for carotid endarterectomy. International guidelines on indications for surgery are followed, and the majority of the patients have symptomatic carotid stenosis occluding > 70% of the lumen of the internal carotid artery. Patients characteristics and indications for surgery are registered
Key inclusion criteria (1 listed)
- Indication for carotid surgery
Key exclusion criteria (1 listed)
- Contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIBrain MRI diagnoses tromboembolic lesions or bleeding to the cerebrum and is part of preoperative diagnostic tests before carotid surgery. After surgery brain MRI may present New lesions related to surgery, clinically significant or insignificant. Our goal is to evaluate the relevance of this modality in carotid surgery.. | Diagnostic test | – |
Primary outcome
Brain lesions on MRI
Time frame: 30 days
Lesions on brain MRI representing thromboembolic or hemorrhagic episodes
1 secondary outcome
Time from Transient Ischemic Attack (TIA) or minor stroke to surgery
Time frame: Days before surgery, maximum 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: Undecided. No plan
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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.
Toril Rabben, PhD principal investigator
Oslo University Hospital, Dep. of Vascular Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenoses, run by Oslo University Hospital.
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 1 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: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain lesions on MRI (time frame: 30 days). 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 23 Jul 2019.