Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514644
Status:
COMPLETED
Last Update Posted:
2012-01-10
First Post:
2007-08-09
Brief Title:
Stroke and Panorama - Analyzing Carotid Endocalcifications SPACE
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
Stroke and Panorama - Analyzing Carotid Endocalcifications
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPACE
Brief Summary:
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
Detailed Description:
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
Subpopulation prevalence of carotid stenoses 50 in persons with calcifications in the area of the carotid arteries seen in a panoramic examination
Secondary endpoints
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
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
Subpopulation prevalence of carotid stenoses 50 in persons with calcifications in the area of the carotid arteries seen in a panoramic examination
Secondary endpoints
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None