The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Haemodynamic aortic valve disease progression.
研究概览
简要总结
The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement.
Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.
详细描述
This will be an observational cohort study using existing and prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of aortic stenosis severity. For existing cohorts of patients who have previously undergone research assessments, we will invite them for repeated assessments.
Participants will be reviewed every 6 months in the Clinical Research Facility (CRF) over a 4-year period. They will undergo clinical assessment, blood sampling, transthoracic echocardiography and advanced imaging annually including CT angiography, magnetic resonance and positron emission tomography (PET).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged >50 years
- •Provision of informed consent prior to any study specific procedures
- •Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves
- •Patients with severe aortic stenosis (peak velocity >4.0 m/s; previously recruited patients)
- •Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients)
- •Patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients)
- •Patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)
- •Age and sex-matched healthy volunteers
排除标准
- •Inability or unwilling to give informed consent.
- •Those with an allergy to iodinated contrast
- •Patients with impaired renal function (eGFR of <30 mL/min/1.73m2)
- •Women who are pregnant or breastfeeding.
- •Patients with known Rheumatic Heart Disease
- •Patients with known Ochronosis
- •Patients with known Familial Homozygous Hypercholesterolaemia
结局指标
主要结局
Haemodynamic aortic valve disease progression.
时间窗: 4 years
Rate of change of maximal aortic valve jet velocity (AV Vmax)
次要结局
- Inflammatory, thrombotic, fibrotic and calcific aortic valve disease progression.(4 years)