A Pilot Study of ELastin Metabolites and Aortic Remodelling Following Surgery for Tricuspid and bICuspid Aortic Stenosis (ELASTIC-AS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Levels of metabolites of elastin turnover
研究概览
简要总结
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. It is also more common for them to develop enlargement of the main blood vessel coming out of the heart, the aorta, and some studies suggest that they are also at higher risk of life-threatening tears in the aortic wall. Current guidelines recommend surgical replacement of the aorta at an earlier stage in these patients. The exact mechanism for the dilatation is not clear, and some studies have suggested greater 'stiffness' in the wall of the aorta. In this study, the investigators propose to 1.) study aortic size, stiffness and flow patterns using MRI in patients with bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in patients' blood that may be important in the process of expansion, 3.) compare the change in MRI and blood markers at before and 12 months after surgery, in patients who are due to have aortic valve replacement surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participant is willing and able to give informed consent for participation in the study.
- •Age 18 years or above.
- •Planned surgical AVR (+/- CABG or aortic root surgery) for severe AS.
- •Ability to understand the written information in English.
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Contraindication to MRI (e.g., non-compatible pacemaker or other device).
- •Severe claustrophobia (unable to have MRI scan).
- •eGFR<30ml/min (contra-indication to have contrast agent during MRI).
- •Contraindication to Adenosine (severe asthma).
- •Significant arrhythmia.
- •Other valve disease > moderate in severity.
- •Female participants who are pregnant or lactating.
- •Previous aortic valve or aorta surgery, previous CABG or other surgery involving aortic cross clamping.
- •Participant in an interventional cardiovascular clinical trial.
结局指标
主要结局
Levels of metabolites of elastin turnover
时间窗: 12 months
Change in levels of metabolites of elastin turnover pre- and post-AVR.
次要结局
- Left ventricular mass index (LVMI) on MRI(12 months)
- Left ventricular ejection fraction (LVEF) on MRI(12 months)
- Aortic distensibility on MRI(12 months)
- Pulse wave velocity on MRI(12 months)