Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

Not Applicable

Completed

• Conditions: Carotid Stenoses
• Interventions: Other: Panorama examination; Other: Carotid ultrasound examination

• Registration Number: NCT00514644
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-09
• Study First Posted: 2007-08-10
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound to Panorama	Panorama examination	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.
Panorama to Ultrasound	Carotid ultrasound examination	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.

Primary Outcome Measures

Name	Time	Method
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication

Trial Locations

Locations (1)

University Hospital in Umea; 🇸🇪 Umea, Västerbotten, Sweden