Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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:

* 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.

Conditions

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Carotid Stenoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Carotid ultrasound examination

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Panorama examination

Intervention Type OTHER

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

Interventions

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Carotid ultrasound examination

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

Intervention Type OTHER

Panorama examination

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No