NCT04280575已完成不适用
Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery
研究概览
简要总结
The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angina or angina-equivalent symptoms
- •Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis
- •Referred for percutaneous coronary intervention for treatment of stable angina
排除标准
- •Age younger than 18
- •Age older than 85
- •Recent acute coronary syndrome
- •Multivessel coronary artery disease
- •Previous coronary artery bypass graft surgery
- •Significant left main stem coronary disease
- •Chronic total occlusion in the target vessel
- •Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
- •Contraindication to antiplatelet therapy
- •Contraindication to adenosine infusion
- •Severe valvular disease
- •Severe LV systolic impairment
- •Severe respiratory disease
- •Life expectancy less than 2 years, pregnancy, unable to consent
结局指标
主要结局
Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery
时间窗: 30 Days
Similarity Score (1-10) (Higher Score = Better Outcome)
次要结局
- Change in angina symptom score(30 Days)
- Change in treadmill time to chest pain(30 Days)
- Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire.(30 Days)
- Quality of Life assessed with the EQ-5D-5L questionnaire(30 Days)
- Need for anti-anginal medication introduction and uptitration(30 Days)
- Change in treadmill exercise time(30 Days)
- Change in dobutamine stress echocardiography score(30 Days)
- Depression as assessed by the PHQ-9 Score(30 days)
- Angina severity as assessed by Canadian Cardiovascular Society Class(30 Days)
- Anxiety as assessed by the GAD-7 Score(30 days)
研究者
研究点 (2)
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