Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
28/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gianni Angelini

ORCID ID

Contact details

Department of Cardiac Surgery
United Bristol Healthcare Trust
Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3145
G.D.Angelini@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/04/06

Study information

Scientific title

Acronym

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: Heart disease

Intervention

1. Direct coronary artery bypass
2. Angioplasty +/- stenting

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

03/05/1999

Overall trial end date

02/10/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

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

United Kingdom

Trial participating centre

Department of Cardiac Surgery
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15080865

Publication citations

  1. HTA monograph

    Reeves BC, Angelini GD, Bryan AJ, Taylor FC, Cripps T, Spyt TJ, Samani NJ, Roberts JA, Jacklin P, Seehra HK, Culliford LA, Keenan DJ, Rowlands DJ, Clarke B, Stanbridge R, Foale R, A multi-centre randomised controlled trial of minimally invasive direct coronary bypass grafting versus percutaneous transluminal coronary angioplasty with stenting for proximal stenosis of the left anterior descending coronary artery., Health Technol Assess, 2004, 8, 16, 1-43.

Additional files

Editorial Notes