Inclusive Invasive Physiological Assessment in Angina Syndromes - Obstructive Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- UMC Utrecht
- 入组人数
- 450
- 主要终点
- Angina symptom burden
研究概览
简要总结
The goal of this clinical trial is to test whether adding coronary function testing and starting targeted medical treatment for identified vasomotor disorders will also improve angina symptoms and quality of life in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention. The main question it aims to answer is:
Does performing coronary function testing in patients with obstructive coronary artery disease who undergo percutaneous coronary intervention lead to better relieve of angina symptoms and improvement in quality of life?
Researchers will compare this group undergoing coronary function testing with a control group who will solely undergo percutaneous coronary intervention.
Participants will:
- Undergo percutaneous coronary intervention and coronary function testing in the intervention arm
- Undergo percutaneous coronary intervention in the control arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Patients >18 years of age
- •Hemodynamically relevant obstructive coronary artery disease (as assessed by pressure wire evaluation) in the left anterior descending coronary artery amenable to percutaneous coronary intervention at the discretion of the operator.
排除标准
- •Prior coronary artery bypass graft surgery.
- •Stenosis >90% in the target vessel or a stenosis deemed unsafe for pressure wire instrumentation
- •Known severe left ventricular dysfunction (left ventricular ejection fraction by any imaging modality)
- •Severe valvular disease
- •Renal impairment (estimated glomerular filtration rate <30mL/min)
- •Contra-indications for the use of adenosine or acetylcholine
- •Expected inability to conform to the clinical follow-up
- •Unable or unwilling to use the ORBITA-app
- •Life expectancy of less than 12 months.
研究组 & 干预措施
Percutaneous coronary intervention
Standard care arm, in which participants will receive their percutaneous coronary intervention (PCI) according to local practice standards and guidelines
干预措施: Percutaneous coronary intervention (Procedure)
Percutaneous coronary intervention + coronary function testing
In the intervention group, participants will receive coronary function testing (CFT) before and after their percutaneous coronary intervention to test for coronary microvascular dysfunction and coronary vasospasm
干预措施: Coronary function testing (Diagnostic Test)
Percutaneous coronary intervention + coronary function testing
In the intervention group, participants will receive coronary function testing (CFT) before and after their percutaneous coronary intervention to test for coronary microvascular dysfunction and coronary vasospasm
干预措施: Percutaneous coronary intervention (Procedure)
结局指标
主要结局
Angina symptom burden
时间窗: From baseline to 6 months of follow-up (after procedure)
The difference in the change in angina symptom score between groups from baseline to 6-month follow-up. Patients will keep track of their symptoms daily during which they can answer the question if they had symptoms with 'yes' or 'no'. If 'yes' is selected, they can select how frequent their attacks were on that day (from 0-10, were 0 = no attack and 10 = 10 or more attacks) and also the severity of the attacks (mild, moderate or severe). A higher score means a worse outcome.
次要结局
- Difference Seattle Angina Questionnaire Summary Score (SAQSS)(From baseline to 6 months of follow-up (after procedure))
- Difference Canadian Cardiovascular Society (CCS) grading of angina pectoris(From baseline to 6 months of follow-up (after procedure))
- Difference Seattle Angina Questionnaire (SAQ)(From baseline to 6 months of follow-up (after procedure))
- Difference EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L)(From baseline to 6 months of follow-up (after procedure))
- Difference Patient Global Impression of Change (PGI-C)(At 6 and 12 months of follow-up (after procedure))
- Prevalence coronary vasomotor disorders(From baseline to 12 months of follow-up (after procedure))
- Disease endotype(From baseline to 12 months of follow-up (after procedure))
- Role coronary computed tomography angiography (CCTA)(From baseline to 12 months of follow-up (after procedure))
- Role of biomarkers(From baseline to 12 months of follow-up (after procedure))
- Adverse events(From baseline to 12 months of follow-up (after procedure))
- Similarity score(From baseline to 12 months of follow-up (after procedure))
- Difference MacNew score(From baseline to 6 months of follow-up (after procedure))
- Canadian Cardiovascular Society (CCS) grading of angina pectoris at 12 months(From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure))
- Seattle Angina Questionnaire (SAQ) at 12 months(From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure))
- Seattle Angina Questtionaire Summary Score (SAQSS) at 12 months(From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure))
- EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L) at 12 months(From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure))
- MacNew at 12 months(From baseline to 12 months and from 6 months to 12 months of follow-up (after procedure))