Site of Disease BIOmolecule Capture and Analysis in PATienTs With Established Coronary Disease undERgoing iNtracoronary Assessment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1
研究概览
简要总结
The aim of this research, proposed and funded by PlaqueTec and co-ordinated by Papworth Trials Unit Collaboration, is to demonstrate the performance of the coronary artery blood sampling device (Liquid Biospy System, LBS) and establish its usefulness to collect a range of disease biomolecules from the coronary artery of interest. Using the data generated from extensive analysis of the blood samples, key biomarker data will be generated that will close a knowledge gap and facilitate the development of tailored treatments for coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Stage 1 screening inclusion:
- •≥18 years of age, have capacity and be willing to provide informed consent to participate
- •Clinical evidence of obstructive coronary artery disease and be scheduled for either:
- •Elective coronary angiography +/- proceed for stable angina OR
- •Elective PCI for stable angina with known bystander disease not for PCI OR
- •Angiography +/- proceed for Troponin negative unstable angina
- •Stage 2 screening inclusion:
- •Suitable lesion identified meeting angiographic criteria for LBS deployment and Cardiologist comfortable to deploy OCT and LBS on study lesion before carrying out PCI on any other lesion
排除标准
- •Stage 1 screening exclusion:
- •Myocardial Infarction within 30 days of procedure.
- •Chronic renal failure (eGFR<30ml/min/1.73m2).
- •Contrast allergy.
- •Hypotension, shock or haemodynamic instability.
- •Ventricular arrhythmia.
- •Chronic Heart Failure (NYHA ≥ 3) or LVEF ≤ 30%.
- •Immunocompromised or receiving immunosuppressant therapy.
- •Any active disease that in the opinion of the investigator makes the subject unsuitable for the research procedure or subject life expectancy less than 1 year.
- •Active infection or sepsis (significant CRP elevation and/or requiring antibiotics).
- •Active systemic inflammatory condition.
- •Inability to receive anticoagulants or antiplatelets or uncorrected bleeding disorder or deranged platelet count.
- •Is pregnant.
- •Deemed high clinical risk or unsuitable for the procedure for any reason by the treating clinician.
- •Stage 2 screening exclusion:
- •Target lesion is in the left main coronary artery.
- •Target lesion requires PCI
- •In same vessel as lesion requiring PCI
- •Unsuitable coronary anatomy (vessel tortuosity [>45 degree bend], moderate/ severe calcification angiographically, ostial disease).
- •Presence of thrombus in the target vessel.
- •Prior PCI or stent in vessel identified for LBS sampling
结局指标
主要结局
Trans-plaque gradients (downstream value divided by upstream value) for LOX-1 and CXCL1
时间窗: Single time point (time of intervention)
Liquid Biopsy System (LBS) performance: successful positioning and successful intracoronary sampling
时间窗: Single time point (time of intervention)
Success define as confirmed adequate positioning of the device across the identified lesion of interest and collection of sufficient whole blood from each functional port to generate \>100µl plasma once processed
次要结局
- Correlations between primary outcome measure proteins and: patient subsets and lesion level data(Single time point (time of intervention))