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Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)
This study is currently recruiting participants.
Verified by Umeå University, June 2008
Sponsored by: Umeå University
Information provided by: Umeå University
ClinicalTrials.gov Identifier: NCT00514644
  Purpose

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.


Condition Intervention
Carotid Stenoses
Other: Carotid ultrasound examination
Other: Panorama examination

U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Stroke and Panorama - Analyzing Carotid Endocalcifications

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Subpopulation prevalence of carotid stenoses in the group of persons in which calcifications in the area of the carotid arteries was spotted during a panoramic examination. [ Time Frame: Directly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Panorama to Ultrasound: Experimental
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.
Other: Carotid ultrasound examination
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
Ultrasound to Panorama: Experimental
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.
Other: Panorama examination
Examination with the odontological radiological method "Panorama", including a frontal verification image

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514644

Contacts
Contact: Elias P Johansson, PhD student +46 (0)90-123 176 ext - elias.johansson@medicin.umu.se

Locations
Sweden, Västerbotten
University Hospital in Umea Recruiting
Umea, Västerbotten, Sweden, 901 85
Principal Investigator: Elias P Johansson, PhD student            
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per G Wester, Prof. Umea University
Principal Investigator: Jan Ahlqvist, Docent Umea University
Principal Investigator: Eva Levring Jäghagen, Lector Umea University
Principal Investigator: Elias P Johansson, PhD Student Umea University
  More Information

Publications:
Responsible Party: Umeå University ( Per Wester )
Study ID Numbers: EJ-8404
Study First Received: August 9, 2007
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00514644  
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
Panorama
Carotid stenoses

Study placed in the following topic categories:
Arterial Occlusive Diseases
Carotid Stenosis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Constriction, Pathologic
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 10, 2009