Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE) (SPACE)
|Carotid Stenoses||Other: Carotid ultrasound examination Other: Panorama examination|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Stroke and Panorama - Analyzing Carotid Endocalcifications|
- The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
|Study Start Date:||August 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: Panorama to Ultrasound
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.
Other: Carotid ultrasound examination
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
Experimental: Ultrasound to Panorama
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.
Other: Panorama examination
Examination with the odontological radiological method "Panorama", including a frontal verification image
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.
- Subpopulation prevalence of carotid stenoses > 50% in persons with calcifications in the area of the carotid arteries seen in a panoramic examination.
- Statistical data (sensitivity, specificity, accuracy, likelihood ratio and predictive values) for panorama to find carotid stenoses with ultrasound as gold standard.
- Qualitative description of the relationship between panoramic calcification images and the removed carotid plaques.
AMENDMENT JUNE 2011: The different arms of the study will be published seperately.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514644
|University Hospital in Umea|
|Umea, Västerbotten, Sweden, 901 85|
|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|