Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elias Johansson, Umeå University
ClinicalTrials.gov Identifier:
NCT00514644
First received: August 9, 2007
Last updated: January 9, 2012
Last verified: January 2012
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Stroke and Panorama - Analyzing Carotid Endocalcifications

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: August 2007
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Carotid ultrasound examination
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
Experimental: 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.
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.

AMENDMENT JUNE 2011: The different arms of the study will be published seperately.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Sweden
University Hospital in Umea
Umea, Västerbotten, Sweden, 901 85
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: Elias Johansson, MD. PhD., Umeå University
ClinicalTrials.gov Identifier: NCT00514644     History of Changes
Other Study ID Numbers: EJ-8404
Study First Received: August 9, 2007
Last Updated: January 9, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
Panorama
Carotid stenoses

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014