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Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

Stroke and Panorama - Analyzing Carotid Endocalcifications

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00514644
Acronym
SPACE
Enrollment
266
Registered
2007-08-10
Start date
2007-08-31
Completion date
2010-02-28
Last updated
2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenoses

Keywords

Panorama, Carotid stenoses

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.

Interventions

Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.

OTHERPanorama examination

Examination with the odontological radiological method Panorama, including a frontal verification image

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Panorama to Ultrasound arm: * Calcifications in the area of the carotid arteries seen och panorama * Ultrasound to Panorama arm: * Known carotid stenosis \> 50% * Must undergo carotid endoarterectomy after the panoramic examination

Exclusion criteria

* Panorama to Ultrasound arm: * Previous cerebrovascular symptoms * Below 18 or above 75 years of age * Ultrasound to Panorama arm: * Below 18 or above 90 years of age

Design outcomes

Primary

MeasureTime frame
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the atheroma on Panoramic examination-indication

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026