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 |
| Protocol serial number | HTA 96/04/06 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Prof Gianni Angelini
Scientific
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 |
|---|---|
| G.D.Angelini@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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. |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Heart disease |
| Intervention | 1. Direct coronary artery bypass 2. Angioplasty +/- stenting |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 02/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 03/05/1999 |
| Date of final enrolment | 02/10/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Cardiac Surgery
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
