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CompletedNCT00514644SPACEUpdated Jan 10, 2012

Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

An interventional study of Carotid ultrasound examination and Panorama examination in Carotid Stenoses, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-01-10.

Sponsored by Umeå University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
266
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Carotid Stenoses

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Keywords

  • Panorama
  • Carotid stenoses
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 266 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
266 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherCarotid ultrasound examination

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

  • OtherPanorama examination

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

06

What researchers measure

Primary outcomes

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

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Study locations

1 site
  • University Hospital in Umea
    Umea, Västerbotten 901 85, Sweden
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References and documents

Publications

  • Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923. PubMed 10796451 ↗
  • 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. PubMed 9510279 ↗
  • 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. PubMed 12464905 ↗
  • 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. PubMed 15966651 ↗
  • 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. PubMed 21752238 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00514644
Lead sponsor
Umeå University
Responsible party
Elias Johansson (MD. PhD., Umeå University) — Principal investigator
First posted
Aug 10, 2007
Start date
Aug 2007
Primary completion
Nov 2009
Completion
Feb 2010
Last update
Jan 10, 2012

Study contacts

Per G Wester, Prof.
principal investigator · Umea University
Jan Ahlqvist, Docent
principal investigator · Umea University
Eva Levring Jäghagen, Lector
principal investigator · Umea University
Elias P Johansson, PhD Student
principal investigator · Umea University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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