Use of Imaging and Blood Biomarkers to Improve the Diagnostic Accuracy of Cardiac Assessment by Stress Echocardiogram
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 23,000
- 主要终点
- Assessment of Prognostically Significant CAD
研究概览
简要总结
EVAREST will identify and validate novel blood and imaging biomarkers of potential value for consistent and accurate interpretation of stress echocardiography. During phase one, blood samples will be collected to assess the impact of cardiac stress on levels of circulating biomarkers and examine whether the measurement of these biomarkers can provide additional prognostic information. Phases one, two and three will also determine whether novel imaging biomarkers can be identified in the echocardiograms that can be used for objective interpretation of the stress echocardiograms. EVAREST will recruit up to 8000 patients (First 500 during phase one, an additional 500 during phase two and an additional 7000 during phase three) from multiple hospitals across United Kingdom, who have been referred for a stress echocardiogram as part of their investigations into ischaemic heart disease. Phase four of the study will continue into a clinical study cohort phase to capture information from all patients referred for a stress echocardiogram in the UK, regardless of the reason for investigation.This registry phase will run for 2 years, recruiting up to 15000 participants.
详细描述
Study Overview:
• Design
EVAREST is a multi-centre observational study comparing accuracy of novel quantitative stress echocardiography biomarkers for prediction of 12 month outcome against standard clinical interpretation.
• Scientific Justification
Coronary artery disease affects 2.3 million people in the UK and is responsible for 66 000 deaths each (BHF, 2018). As such, early diagnosis and intervention is crucial for saving lives and improving people's quality of life. Stress echocardiography is a commonly used, non-invasive imaging test used for detection of prognostically significant coronary artery disease. It allows the detection of regional wall motion abnormalities (RWMAs) which develop when the myocardium is not receiving adequate perfusion and, as such, indicates obstructive coronary artery disease. Average sensitivity and specificity for stress echocardiography is estimated at 81% and 82%, respectively (Geleijnse et al., 2009) in meta-analysis but remains highly subjective (Hoffmann et al., 1996) and subject to operator skill (Picano et al., 1991). Objective, quantifiable biomarkers in blood samples, or from images, acquired during the stress echocardiogram, which predict outcome of patients, could be used to reduce variability of stress echocardiography and ensure consistent and accurate results.
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
- •Patients must be undergoing a stress echocardiogram to investigate the presence of ischaemic heart disease (groups 1-3).
- •Patients must be able to provide informed consent.
- •Patients must be aged over 18 years of age.
排除标准
- •Patients undergoing stress echocardiography to assess valvular function.
- •Patients who are unwilling or unable to provide informed consent.
- •Patients aged under 18 years of age.
结局指标
主要结局
Assessment of Prognostically Significant CAD
时间窗: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Patients will be followed up one year after their stress echocardiogram to determine whether they have prognostically significant CAD. This is defined as \>70% stenosis assessed by angiography (either via invasive coronary angiography or CT coronary angiography), an FFR\< 0.85 or the intention to revascularize (either via PCI or CABG). Any tests that occur in a ten year period after the stress echocardiogram will also be recorded.
Examination of Medical Records
时间窗: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Medical records will also be examined to check for any acute coronary syndromes within the year following the stress echocardiogram. Participants will also be contacted by telephone to capture any out-of-hospital events. Further follow-up data will be captured up to 10 years after the patient's initial stress echocardiogram.
次要结局
- Quantification of Extracellular Vesicles (obtained from blood samples) by Flow Cytometry(Blood samples will be obtained before and after the stress echocardiogram. Analysis will be complete one year from the date of the stress echocardiogram)
- Assessment of Time to Diagnosis(Data will be collected for ten years after the patient undergoes the stress echocardiogram.)
- Investigation into the use of stress echocardiography as a clinical procedure in the UK.(Data will be collected for ten years after the patient undergoes the stress echocardiogram.)
- Analysis of Potential Cost Savings Through the Use of Novel Biomarkers By the Reduction in Unnecessary Procedures(Data will be collected for ten years after the patient undergoes the stress echocardiogram.)