Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina

Study Overview
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Brief Summary
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In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.

Detailed Description
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The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.

Official Title
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Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease

Conditions
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Stable Angina

Intervention / Treatment
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* Procedure: Coronary angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation Exclusion Criteria: Acute coronary syndrome Previous coronary artery bypass graft surgery Left main stem disease Contraindications to PCI or drug-eluting stent (DES) implantation Heavily calcified or tortuous vessels Chronic total occlusion in target vessel Life expectancy <2yr Pregnancy Age <18yr or >85yr Angiographic stenosis ≥ 50% in non-target vessel Inability 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coronary angioplasty and optimum medical therapy<br>Percutaneous coronary intervention and optimal medical therapy | Procedure: Coronary angioplasty<br>* Percutaneous coronary intervention with drug-eluting stents and modern techniques<br>* Other names: Percutaneous coronary intervention;|
| Placebo Comparator: Sham procedure and optimum medical therapy<br>Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy | Procedure: Coronary angioplasty<br>* Percutaneous coronary intervention with drug-eluting stents and modern techniques<br>* Other names: Percutaneous coronary intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Time on Treadmill |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable angina, Percutaneous coronary intervention, Optimal medical therapy, Sham-control