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

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.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Sussex Healthcare NHS Trust, Saint Leonards-on-Sea, East Sussex, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary angioplasty

Procedure

Percutaneous coronary intervention with drug-eluting stents and modern techniques

Other names: Percutaneous coronary intervention

Primary outcomes

Exercise Time on Treadmill

Time frame: 6 weeks

Measured in seconds on Modified Bruce exercise treadmill protocol

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

Volcano Corporation

Registry information

Official study title

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

Acronym: ORBITA

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Feb 13, 2014
Registry last updated: Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed