Stroke and Panorama - Analyzing Carotid Endocalcifications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Carotid ultrasound examination (Other)
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.
干预措施: Panorama examination (Other)
结局指标
主要结局
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
次要结局
未报告次要终点