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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
230
Percutaneous coronary intervention with drug-eluting stents and modern techniques
East Sussex Healthcare NHS Trust
Saint Leonards-on-Sea, East Sussex, United Kingdom
Basildon and Thurrock University Hospitals NHS Trust
Basildon, United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Trust
Bournemouth, United Kingdom
Royal Devon & Exeter Foundation Trust
Exeter, United Kingdom
Exercise Time on Treadmill
Measured in seconds on Modified Bruce exercise treadmill protocol
Time frame: 6 weeks
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Imperial College Healthcare NHS Trust
London, United Kingdom