Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

Umeå University

Status: Completed

Conditions: Carotid Stenoses

Treatments: Other: Carotid ultrasound examination; Other: Panorama examination

Study type: Interventional

Funder types: Other

Identifiers

NCT00514644

EJ-8404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

266 participants in 2 patient groups

Panorama to Ultrasound

Experimental group

Description:

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.

Treatment:

Other: Carotid ultrasound examination

Ultrasound to Panorama

Experimental group

Description:

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.

Treatment:

Other: Panorama examination