Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE) — SPACE  

Carotid Stenoses Clinical Trial

Official title: Stroke and Panorama - Analyzing Carotid Endocalcifications

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carotid Stenoses
• Carotid Stenosis

• NCT number: NCT00514644
• Study type: Interventional
• Source: Umeå University
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Completion date: February 2010