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Sponsored by: |
Umeå University |
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Information provided by: | Umeå University |
ClinicalTrials.gov Identifier: | NCT00514644 |
The odontological radiology method Panorama is known to be able to spot calcifications in the area of the carotid arteries. The calcifications could be carotid stenoses which is affiliated with an increased risk of stroke. The study aims to investigate if panorama examinations can be used as a starting point for further investigation of the carotid arteries.
Condition | Intervention |
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Carotid Stenoses |
Other: Carotid ultrasound examination Other: Panorama examination |
Study Type: | Interventional |
Study Design: | Diagnostic, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Stroke and Panorama - Analyzing Carotid Endocalcifications |
Estimated Enrollment: | 200 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Panorama to Ultrasound: Experimental
100 asymptotic patients that have findings of calcifications in the area of the carotid arteries when examined with panorama. These persons are examined with carotid ultrasound.
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Other: Carotid ultrasound examination
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
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Ultrasound to Panorama: Experimental
100 patients with a known carotid stenosis seen on ultrasound will be examined with panorama before any intervention is made. These patients must undergo surgery to be finally included.
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Other: Panorama examination
Examination with the odontological radiological method "Panorama", including a frontal verification image
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We intend to examinate 100 consecutive persons that have calcifications in the area of the carotid arteries with carotid duplex-ultrasound. The prevalence of carotid stenoses > 50% (According to the NASCET criteria) in this group is the primary result of interest, answering the most fundamental question - should persons with calcifications in the area of the carotid arteries seen on panorama be screened with ultrasound in order to find asymptomatic carotid stenoses? Since the publication of the ACST and the ACAS studies it is clear that some of these patients might have indications for surgery.
A second part of the study aims to more fully understand what it is that the panorama examination reveals. In this part will 100 patients that are going to undergo surgery to remove their carotid stenoses will be examined with panorama. The carotid plaque that is removed during the surgery will be examined radiologically.
Primary endpoint:
Secondary endpoints:
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Panorama to Ultrasound arm:
Ultrasound to Panorama arm:
Exclusion Criteria:
Panorama to Ultrasound arm:
Ultrasound to Panorama arm:
Contact: Elias P Johansson, PhD student | +46 (0)90-123 176 ext - | elias.johansson@medicin.umu.se |
Sweden, Västerbotten | |
University Hospital in Umea | Recruiting |
Umea, Västerbotten, Sweden, 901 85 | |
Principal Investigator: Elias P Johansson, PhD student |
Principal Investigator: | Per G Wester, Prof. | Umea University |
Principal Investigator: | Jan Ahlqvist, Docent | Umea University |
Principal Investigator: | Eva Levring Jäghagen, Lector | Umea University |
Principal Investigator: | Elias P Johansson, PhD Student | Umea University |
Responsible Party: | Umeå University ( Per Wester ) |
Study ID Numbers: | EJ-8404 |
Study First Received: | August 9, 2007 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00514644 |
Health Authority: | Sweden: The National Board of Health and Welfare |
Panorama Carotid stenoses |
Arterial Occlusive Diseases Carotid Stenosis Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Constriction, Pathologic Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |