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Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE) (SPACE)

Primary Purpose

Carotid Stenoses

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Carotid ultrasound examination
Panorama examination
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Stenoses focused on measuring Panorama, Carotid stenoses

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital in Umea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Panorama to Ultrasound

Ultrasound to Panorama

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 9, 2007
Last Updated
January 9, 2012
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT00514644
Brief Title
Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)
Acronym
SPACE
Official Title
Stroke and Panorama - Analyzing Carotid Endocalcifications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenoses
Keywords
Panorama, Carotid stenoses

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panorama to Ultrasound
Arm Type
Experimental
Arm 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.
Arm Title
Ultrasound to Panorama
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Carotid ultrasound examination
Intervention Description
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
Intervention Type
Other
Intervention Name(s)
Panorama examination
Intervention Description
Examination with the odontological radiological method "Panorama", including a frontal verification image
Primary Outcome Measure Information:
Title
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per G Wester, Prof.
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Ahlqvist, Docent
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Levring Jäghagen, Lector
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elias P Johansson, PhD Student
Organizational Affiliation
Umea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital in Umea
City
Umea
State/Province
Västerbotten
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
10796451
Citation
Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923.
Results Reference
background
PubMed Identifier
9510279
Citation
Yin D, Carpenter JP. Cost-effectiveness of screening for asymptomatic carotid stenosis. J Vasc Surg. 1998 Feb;27(2):245-55. doi: 10.1016/s0741-5214(98)70355-6.
Results Reference
background
PubMed Identifier
12464905
Citation
Almog DM, Horev T, Illig KA, Green RM, Carter LC. Correlating carotid artery stenosis detected by panoramic radiography with clinically relevant carotid artery stenosis determined by duplex ultrasound. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Dec;94(6):768-73. doi: 10.1067/moe.2002.128965.
Results Reference
background
PubMed Identifier
15966651
Citation
Friedlander AH, Garrett NR, Chin EE, Baker JD. Ultrasonographic confirmation of carotid artery atheromas diagnosed via panoramic radiography. J Am Dent Assoc. 2005 May;136(5):635-40; quiz 682-3. doi: 10.14219/jada.archive.2005.0235.
Results Reference
background
PubMed Identifier
21752238
Citation
Johansson EP, Ahlqvist J, Garoff M, Karp K, Jaghagen EL, Wester P. Ultrasound screening for asymptomatic carotid stenosis in subjects with calcifications in the area of the carotid arteries on panoramic radiographs: a cross-sectional study. BMC Cardiovasc Disord. 2011 Jul 13;11:44. doi: 10.1186/1471-2261-11-44.
Results Reference
result

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Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

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