NCT00514644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

August 9, 2007

Last Update Submit

January 9, 2012

Conditions

Carotid Stenoses

Keywords

PanoramaCarotid stenoses

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

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

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

Interventions

Carotid ultrasound examinationOTHER

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

Panorama to Ultrasound
Panorama examinationOTHER

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

Ultrasound to Panorama

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital in Umea

Umeå, Västerbotten County, 901 85, Sweden

Location

Related Publications (5)

  • Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923.

    PMID: 10796451BACKGROUND

  • 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.

    PMID: 9510279BACKGROUND

  • 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.

    PMID: 12464905BACKGROUND

  • 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.

    PMID: 15966651BACKGROUND

  • 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.

    PMID: 21752238RESULT

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

August 1, 2007

Primary Completion

November 1, 2009

Study Completion

February 1, 2010

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations

SE(1)