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出境医 / 临床实验 / Pre- and Post-operative Brain MRI in Carotid Endarterectomy
Pre- and Post-operative Brain MRI in Carotid Endarterectomy
Study Description
Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Carotid Artery Stenoses | Diagnostic Test: 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
| Study Type : | Observational |
| Actual Enrollment : | 320 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy |
| Actual Study Start Date : | January 1, 2005 |
| Actual Primary Completion Date : | December 31, 2016 |
| Actual Study Completion Date : | December 31, 2017 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Brain lesions on MRI [ Time Frame: 30 days ]Lesions on brain MRI representing thromboembolic or hemorrhagic episodes
Secondary Outcome Measures :
- Time from Transient Ischemic Attack (TIA) or minor stroke to surgery [ Time Frame: Days before surgery, maximum 6 months ]International guidelines recommends surgery within 14 days after TIA
Other Outcome Measures:
- Complications to carotid surgery [ Time Frame: Within 30 days after surgery ]TIA, minor stroke, nerve damage
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | August 3, 2017 | ||||
| First Posted Date | July 23, 2019 | ||||
| Last Update Posted Date | July 23, 2019 | ||||
| Actual Study Start Date | January 1, 2005 | ||||
| Actual Primary Completion Date | December 31, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Brain lesions on MRI [ Time Frame: 30 days ] Lesions on brain MRI representing thromboembolic or hemorrhagic episodes
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Time from Transient Ischemic Attack (TIA) or minor stroke to surgery [ Time Frame: Days before surgery, maximum 6 months ] International guidelines recommends surgery within 14 days after TIA
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
Complications to carotid surgery [ Time Frame: Within 30 days after surgery ] TIA, minor stroke, nerve damage
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title | Pre- and Post-operative Brain MRI in Carotid Endarterectomy | ||||
| Official Title | Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy | ||||
| Brief 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. | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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 | ||||
| Condition | Carotid Artery Stenoses | ||||
| Intervention | Diagnostic Test: Brain MRI
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..
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| Study Groups/Cohorts | Not Provided | ||||
| 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 | Completed | ||||
| Actual Enrollment |
320 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 31, 2017 | ||||
| Actual Primary Completion Date | December 31, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04029259 | ||||
| Other Study ID Numbers | MR caput and CEA | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Toril Rabben, Oslo University Hospital | ||||
| Study Sponsor | Oslo University Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Oslo University Hospital | ||||
| Verification Date | July 2019 | ||||
