Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE) (SPACE)
Stroke and Panorama - Analyzing Carotid Endocalcifications
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Västerbotten
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Umea, Västerbotten, 스웨덴, 901 85
- University Hospital in Umea
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
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실험적: 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.
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Examination with the odontological radiological method "Panorama", including a frontal verification image
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Per G Wester, Prof., Umeå University
- 수석 연구원: Jan Ahlqvist, Docent, Umeå University
- 수석 연구원: Eva Levring Jäghagen, Lector, Umeå University
- 수석 연구원: Elias P Johansson, PhD Student, Umeå University
간행물 및 유용한 링크
일반 간행물
- Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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