Symptomatic Trial of Angina Assessment Prior to Revascularization

Study Overview
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Brief Summary
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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.

Official Title
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Symptomatic Trial of Angina Assessment Prior to Revascularization: A Placebo-controlled Experiment on Symptoms in Stable Coronary Artery Disease

Conditions
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Coronary Artery Disease, Angina, Stable

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous coronary intervention|Coronary artery stenting for stable angina|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placebo controlled similarity score during low pressure balloon occlusion of the coronary artery | Similarity Score (1-10) (Higher Score = Better Outcome) | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in angina symptom score | Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome) | 30 Days | 
| Change in treadmill exercise time |  | 30 Days | 
| Change in treadmill time to chest pain |  | 30 Days | 
| Angina severity as assessed by Canadian Cardiovascular Society Class | Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome) | 30 Days | 
| Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire. | Seattle Angina Questionnaire, (Lower Score = Better Outcome) | 30 Days | 
| Quality of Life assessed with the EQ-5D-5L questionnaire | (Lower Score = Better Outcome) | 30 Days | 
| Change in dobutamine stress echocardiography score | (Lower Score = Better Outcome) | 30 Days | 
| Need for anti-anginal medication introduction and uptitration |  | 30 Days | 
| Anxiety as assessed by the GAD-7 Score | Generalised anxiety and depression - 7 Score. (Lower Score = Better Outcome) | 30 days | 
| Depression as assessed by the PHQ-9 Score | Patient Health Questionnaire - 9. (Lower Score = Better Outcome) | 30 days |