Clinical trial NCT00514644: Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)
Official title: Stroke and Panorama - Analyzing Carotid Endocalcifications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenoses
Keywords: Panorama
Carotid stenoses
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2007-08-10
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
Secondary outcomes:
Other outcomes:
Locations:
city: Umea
country: Sweden
facility: University Hospital in Umea
state: Västerbotten
Study officials:
affiliation: Umea University
name: Per G Wester, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Umea University
name: Jan Ahlqvist, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Umea University
name: Eva Levring Jäghagen, Lector
role: PRINCIPAL_INVESTIGATOR
affiliation: Umea University
name: Elias P Johansson, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.