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

Stable Angina Clinical Trial

— ORBITA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062593
• Other study ID #: ORBITA-1
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: September 2017

Study information

• Verified date: January 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina

Intervention

Procedure:
• Coronary angioplasty
Percutaneous coronary intervention with drug-eluting stents and modern techniques

Locations

Country	Name	City	State
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	Imperial College Healthcare NHS Trust	London
United Kingdom	East Sussex Healthcare NHS Trust	Saint Leonards-on-sea	East Sussex

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Volcano Corporation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Time on Treadmill	Measured in seconds on Modified Bruce exercise treadmill protocol	6 weeks