Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE) (SPACE)
Stroke and Panorama - Analyzing Carotid Endocalcifications
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Västerbotten
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Umea、Västerbotten、瑞典、901 85
- University Hospital in Umea
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
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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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合作者和调查者
调查人员
- 首席研究员:Per G Wester, Prof.、Umeå University
- 首席研究员:Jan Ahlqvist, Docent、Umeå University
- 首席研究员:Eva Levring Jäghagen, Lector、Umeå University
- 首席研究员:Elias P Johansson, PhD Student、Umeå University
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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