Coronary artery grafting in high risk patients randomised to off-pump or on-pump surgery

ISRCTN ISRCTN29161170
DOI https://doi.org/10.1186/ISRCTN29161170
Protocol serial number MRC ref: G0700469
Sponsor University of Oxford (UK)
Funder Medical Research Council (MRC) (UK) (ref: G0700469)
Submission date
28/07/2008
Registration date
31/10/2008
Last edited
12/06/2015
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Taggart
Scientific

Nuffield Department of Surgery
University of Oxford
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

david.taggart@orh.nhs.uk

Study information

Primary study designInterventional
Study designInternational multicentre open randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCoronary artery grafting in high risk patients randomised to off-pump or on-pump surgery
Study acronymCRISP
Study objectivesOff-pump coronary artery bypass grafting (OPCABG) reduces mortality and morbidity in high risk patients, without a higher risk of reintervention, when compared to on-pump coronary artery bypass grafting (ONCABG).

More details can be found at http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700469&CaseId=9693
Ethics approval(s)Application has been submitted to the Scotland A Research Ethics Committee (ref: 08/MRE00/58). Approval pending as of 28/07/2008.
Health condition(s) or problem(s) studiedCoronary heart disease
InterventionThis study is an international, multicentre open randomised controlled trial, across 40 centres: 20 in the UK and 20 overseas. Trial patients will be randomised to:
1. CABG without cardiopulmonary bypass, i.e. off-pump CABG (OPCABG) on the beating heart, via a median sternotomy incision
2. CABG with cardiopulmonary bypass i.e. on-pump CABG (ONCABG) on a chemically arrested heart, via a median sternotomy incision

Total duration of follow-up is 1 year post-surgery.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

The primary outcome is a composite endpoint of death or serious morbidity (CRISPS). This is made up of the following:
1. Death after cardiac surgery within 30 days of the operation from any cause
2. New onset renal failure requiring renal replacement therapy up to and including 30 days of the operation
3. Myocardial infarction up to and including 30 days of the operation
4. Stroke up to and including 30 days of the operation
5. Prolonged ventilation greater than or equal to 96 hours during the index hospital admission
6. Sternal wound dehiscence requiring non-pharmacological intervention up to and including 30 days of the operation

Key secondary outcome measure(s)

1. Duration of intensive care stay
2. Duration of hospital stay
3. Survival, free from death or serious morbidity at one year
4. Resource use (hospital and other healthcare resources) during one year
5. Quality of life at one year: Rose Angina Questionnaire (short), EuroQol EQ-5D, the Coronary Revascularisation Outcome Questionnaire (CROQ; UK patients only)
6. Cost-effectiveness

Data will be collected on events between discharge and 30 days at a routine follow-up appointment 4 - 8 weeks after discharge. Questionnaires will be completed by the patient before surgery, at the 4 - 8 week follow-up appointment, and will be posted to patients for completion at 1 year post-surgery.

Completion date24/03/2011
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration5420
Key inclusion criteriaCurrent information as of 05/03/2010:
Patients having isolated CABG surgery will be eligible if they satisfy the following criteria:
1. Euroscore ≥5
2. Non-emergency surgery
3. Operation to be carried out via a median sternotomy
4. Written informed patient consent

Initial information at time of registration:
Patients having isolated CABG surgery will be eligible if they satisfy the following criteria:
1. Patients (male or female) aged greater than or equal to 70 years
2. Male patients under 70 years of age with moderate or poor left ventricular function (ejection fraction less than 50%)
3. Euroscore greater than or equal to 5
4. Non-emergency surgery
5. Operation to be carried out via a median sternotomy
6. Written informed patient consent
Key exclusion criteriaCurrent information as of 05/03/2010:
1. Euroscore <5
2. Emergency operation (immediate revascularisation for haemodynamic instability)
3. Concomitant cardiac procedure with CABG
4. Operation to be carried out via an incision other than a median sternotomy (e.g. anterolateral left thoracotomy)
5. Known contraindication to ONCABG or OPCABG (e.g. calcified aorta, calcified coronaries, small target vessels)

Initial information at time of registration:
1. Male patient under 70 years of age with good left ventricular function (ejection fraction greater than 50%)
2. Euroscore less than 5
3. Emergency operation (immediate revascularisation for haemodynamic instability)
4. Concomitant cardiac procedure with CABG
5. Operation to be carried out via an incision other than a median sternotomy (e.g. anterolateral left thoracotomy)
6. Contraindication to ONCABG or OPCABG (e.g. calcified aorta, intramuscular left anterior descending [LAD], calcified coronaries, small target vessels)
Date of first enrolment01/01/2009
Date of final enrolment24/03/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2014 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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