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NCT Number: NCT00514644

Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital in Umea

Umeå, Västerbotten County, 901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotid ultrasound examination

Other

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

Panorama examination

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

Stroke and Panorama - Analyzing Carotid Endocalcifications

Acronym: SPACE

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 10, 2007
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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