Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Intra-individual difference in FFR and NHPR angina thresholds
研究概览
简要总结
ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
During cardiac catheterisation, there will be one blinded component to verify the reproducibility of symptoms against placebo. One true and one placebo balloon inflation will be performed, in a randomised order. Both the participant and outcome assessor will be blinded to the order of true or placebo balloon inflation. The participant will be asked to report any symptoms they have.
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
- •Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
- •2 severe epicardial stenoses in a major coronary artery, defined as:
- •≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)
- •Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA
- •Evidence of ischaemia on an invasive or non-invasive test, including:
- •Physiological test during invasive coronary angiography (ICA)
- •Dobutamine stress echocardiography (DSE)
- •Stress perfusion cardiac magnetic resonance (CMR)
- •Myocardial perfusion scintigraphy (MPS)
- •Fractional flow reserve computed-tomography (FFR-CT)
排除标准
- •Age <18 years
- •Acute coronary syndrome within 3 months
- •Previous coronary artery bypass graft
- •Significant left main stem disease
- •Single lesion amenable to PCI
- •Chronic total occlusion of the target artery
- •Moderate to severe valve disease
- •LVEF ≤40%, contraindication to PCI or drug-eluting stents
- •PCI performed with drug-eluting balloons without stenting
- •Contraindication to antiplatelet therapy
- •Contraindication to adenosine
- •Physical inability to exercise with an ergometer
- •Femoral artery access
- •Inability to consent
研究组 & 干预措施
Patients with stable coronary artery disease
- Symptoms of stable angina
- Evidence of ischaemia on an invasive or non-invasive test
- Two coronary stenoses amenable to percutaneous coronary intervention (PCI)
干预措施: Percutaneous coronary intervention (PCI) (Procedure)
Patients with stable coronary artery disease
- Symptoms of stable angina
- Evidence of ischaemia on an invasive or non-invasive test
- Two coronary stenoses amenable to percutaneous coronary intervention (PCI)
干预措施: Measurement of the angina threshold (Diagnostic Test)
结局指标
主要结局
Intra-individual difference in FFR and NHPR angina thresholds
时间窗: Intra-procedural
Difference in invasively measured physiological angina thresholds at the site of the 2 stents within each participant, stratified by vascular territory and lesion location along a vessel.
次要结局
- Correlation of the angina threshold with baseline symptoms, quality of life and pain perception(14 days)
- Correlation of the angina threshold with other invasive physiological assessments(Intra-procedural)
- Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA)(14 days)
- Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA)(14 days)
- Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging(Intra-procedural)
- Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan(14 days)