A multi-centre randomised controlled trial of minimally invasive bypass grafting vs angioplasty with stenting for single vessel disease of the left anterior descending coronary artery

ISRCTN	ISRCTN38733901
DOI	https://doi.org/10.1186/ISRCTN38733901
Secondary identifying numbers	HTA 96/04/06

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Gianni Angelini
Scientific

Department of Cardiac Surgery
United Bristol Healthcare Trust
Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3145
Email	G.D.Angelini@bristol.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	A multi-centre randomised controlled trial of minimally invasive bypass grafting vs angioplasty with stenting for single vessel disease of the left anterior descending coronary artery
Study hypothesis	Coronary artery bypass grafting and angioplasty =/- stenting are both effective but expensive treatments for coronary heart disease. Cheaper alternative procedures with equal or better effectiveness could achieve substantial savings for the NHS. For patients with single vessel disease, Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) is an alternative procedure to angioplasty, which is the "first-line" procedure for this group of patients. Preliminary findings indicate MIDCAB is more effective and potentially cheaper than angioplasty +/- stenting.
Ethics approval(s)	Not provided at time of registration.
Condition	Cardiovascular diseases: Heart disease
Intervention	1. Direct coronary artery bypass 2. Angioplasty +/- stenting
Intervention type	Other
Primary outcome measure	The study will assess clinical (recurrence of symptoms, adverse clinical events), functional (exercise ECG, symptom questionnaire), quality of life outcomes (EuroQol, GHQ, and cardiac-specific questionnaires) and health service use (contacts with primary care teams, diagnostic investigations, readmissions, etc) and associated costs. All study patients will be followed for a minimum of 1 year.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	03/05/1999
Overall study end date	02/10/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration.
Participant inclusion criteria	Not provided at time of registration.
Participant exclusion criteria	Not provided at time of registration.
Recruitment start date	03/05/1999
Recruitment end date	02/10/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Cardiac Surgery

Bristol
BS2 8HW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/04/2004		Yes	No

Editorial Notes

08/11/2022: Internal review.