使用新型成像技术估计健康主动脉和动脉瘤主动脉的生物力学主动脉壁特性
The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.
研究概览
详细说明
Patients with Abdominal Aortic Aneurysm, (AAA), will be identified within the vascular surgery practice. Those patients who meet standard indications for surgery including symptomatic AAA, size >5.0-5.5 cm, or rapidly enlarging >0.5 cm per 6 months will have standard pre-operative work-up which includes magnetic resonance angiogram (MRA) and Echocardiogram (ECHO). These pre-operative studies will be modified for the study patients to include electrocardiogram(ECG)-gating (coupled with MR angiogram) and 2-Dimensional speckle-tracking ultrasound of the abdominal aorta. Patients in the study will be followed for 1 year. Measurements will be analyzed for any relationship between aortic wall properties and clinical outcomes such as aneurysm growth, rupture risk or aortic dissection. This study will be comparing 3 groups of patients: no surgery (surveillance), open surgery, and endovascular aneurysm repair (EVAR).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Houssam Farres, MD
- 电话号码：904-953-2077
- 邮箱：farres.houssam@mayo.edu
研究联系人备份
- 姓名：Mauricia Buchanan, RN
- 电话号码：904-953-2077
- 邮箱：buchanan.mauricia@mayo.edu
学习地点
-
-
Florida
-
Jacksonville、Florida、美国、32224
- 招聘中
- Mayo Clinic Florida
-
-
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:
- Patients >18 years of age with ability to provide informed consent.
- Patients with either symptomatic or asymptomatic AAA as defined by aortic diameter ≥ 1.5x normal diameter.
- Patients with non-aneurysmal aortas who require aortic contrast imaging or echocardiography for preoperative planning or other reason.
Exclusion Criteria:
- Patients with contraindication to IV contrast such as allergy or severe kidney dysfunction.
- Patients who do not require contrast imaging or echocardiogram as part of their care plan.
- Terminally ill patients, and patients with estimated life expectancy of ≤ 6 months.
- Patients unable to tolerate magnetic resonance imaging.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Surveillance
No Surgery with ECHO and ECG-gated MRA imaging. |
Imaging Imaging |
|
有源比较器：Surgery-Open
Open Surgery with ECHO and ECG-gated MRA imaging. |
Imaging Imaging |
|
有源比较器：Surgery-EVAR
EVAR with ECHO and ECG-gated MRA imaging. |
Imaging Imaging |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ECHO Imaging
大体时间：Change from baseline in ECHO imaging measurements
|
Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds. |
Change from baseline in ECHO imaging measurements
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ECG-gated MRA Imaging
大体时间：Change from baseline ECG-gated imaging measurements.
|
The MRA imaging will be taken with the ECG-gating to synchronize the timing of the image acquisition with cardiac motion. This will allow for more accurate measurement of vessel diameter measured in mm (millimeters) and reported in percent change from baseline. |
Change from baseline ECG-gated imaging measurements.
|
合作者和调查者
赞助
调查人员
- 首席研究员：Houssam Farres, MD、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.