Clinical Predictive Value of Podocan and Wnt Regulatory Molecules in Development of Aortopathy in Bicuspid Aortic Valve Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Circulatory podocon levels
研究概览
简要总结
Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to play role in abnormal aortic distensibility and stiffness with impairment of aortic elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not understood completely. In a recent study podocan is found in extracellular matrix (ECM) of human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no current effective therapy that can alter the progression of aortic dilatation in bicuspid valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta and aortic dissection. In this study the aim is to investigate the association between podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide more effective and physiological understanding of disease process and potential target in prevention and treatment for aortopathy.
详细描述
Patients with known BAV will be enrolled in two inclusion criteria categories:
- Group A: Patients who are scheduled to have a cardiac MRI
Procedures for Group A: MRI will be used as a standard procedure to confirm the morphology of bicuspid valve especially in uncertain cases and to do accurate aortic measurements. Patients who agree to participate will provide informed consent prior to their cardiac MRI/CT. A 6 minute walk test to measure baseline functional status will be performed after consent. All patients having a cardiac MRI/CT have an IV line placed as normal procedure. When then line has been placed, prior to contrast infusion a blood sample will be collected to test for circulatory Podocan and Wnt pathway molecules. At 24 months post procedure the following information will be collected from the participants' charts for endpoint analysis:
-
All cause mortality
-
Hospital admissions for Aortic dissection, Congestive heart failure, endocarditis or cardiac death
-
Valve replacement or aortic graft surgery
-
Group B: Patients who have already had an MRI within the past year
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or greater
- •Patients with known BAV diagnosed by echocardiography, previous MRI, or cardiac CT
- •Scheduled for cardiac MRI or have had a cardiac MRI within the past year
- •Able to provide informed consent
- •Ambulatory and expected to be able to complete 6 minute walk test
排除标准
- •Patients without BAV
- •Patients who have already had surgery for aortic valve problems and/or aortopathy
- •Unable to complete 6 minute walk test (ex. Wheelchair bound)
结局指标
主要结局
Circulatory podocon levels
时间窗: Day 1
circulatory WNT pathway molecule levels
时间窗: Day1
次要结局
- podocon expression in aortic tissue(24 months)
- WNT pathway molecule expression in aortic tissue(24 months)
研究者
Daniel Katz
Attending Physician - Cardiology
Bassett Healthcare