Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

Carotid Stenoses Clinical Trial

— SPACE  

Official title:

Stroke and Panorama - Analyzing Carotid Endocalcifications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514644
• Other study ID #: EJ-8404
• Status: Completed
• Phase: N/A
• First received: August 9, 2007
• Last updated: January 9, 2012
• Start date: August 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2012
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carotid Stenoses
• Carotid Stenosis

Intervention

Other:
• Carotid ultrasound examination
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
• Panorama examination
Examination with the odontological radiological method "Panorama", including a frontal verification image

Locations

Country	Name	City	State
Sweden	University Hospital in Umea	Umea	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. Review. Update in: Cochrane Database Syst Rev. 2005;(4):CD001923. — View 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. — View Citation

Johansson EP, Ahlqvist J, Garoff M, Karp K, Jäghagen 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 — View Citation

Yin D, Carpenter JP. Cost-effectiveness of screening for asymptomatic carotid stenosis. J Vasc Surg. 1998 Feb;27(2):245-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication			No