NCT05459051招募中不适用
Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- The FFR and NHPR value at which the patient experiences angina in a rest state
研究概览
简要总结
ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
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
- •Eligibility for percutaneous coronary intervention (PCI) due to angina or angina-equivalent symptoms on exertion
- •Anatomical evidence of significant single-vessel coronary stenosis defined by either:
- •≥70% stenosis on invasive coronary angiography (ICA)
- •Severe stenosis on CT coronary angiography (CTCA)
- •Physiological evidence of ischaemia with a positive test on at least one of the following:
- •Stress echocardiography
- •Cardiac magnetic resonance perfusion
- •Myocardial perfusion scintigraphy
- •Invasive metrics of coronary physiology
排除标准
- •Age <18 years
- •Recent acute coronary syndrome
- •Previous coronary artery by-pass graft
- •Significant left main stem disease
- •Multivessel disease (defined as >50% angiographic stenosis in other vessels)
- •Chronic total occlusion in the target artery
- •Moderate to severe valvular disease
- •Moderate to severe left ventricular impairment
- •Chronotropic incompetence with a pacemaker
- •Contraindication to PCI or a drug-eluting stents
- •Contraindication to antiplatelet therapy
- •Contraindication to adenosine
- •Moderate to severe respiratory disease
- •Physical inability to exercise
- •Inability to consent
结局指标
主要结局
The FFR and NHPR value at which the patient experiences angina in a rest state
时间窗: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
The FFR and NHPR value at which the patient experiences angina in an exercise state
时间窗: Intra-procedural
Values 0.00-1.00 (Lower = More significant disease)
次要结局
- The NHPR difference between the rest and exercise states(Intra-procedural)
- The FFR difference between the rest and exercise states(Intra-procedural)
- Angina severity score at the angina threshold(Intra-procedural)
- Angina similarity score at the angina threshold(Intra-procedural)
- Angina symptom type at the angina threshold(Intra-procedural)
研究者
研究点 (6)
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