Contact information
Type
Scientific
Primary contact
Prof David Taggart
ORCID ID
Contact details
Nuffield Department of Surgery
University of Oxford
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
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david.taggart@orh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G0700469
Study information
Scientific title
Coronary artery grafting in high risk patients randomised to off-pump or on-pump surgery
Acronym
CRISP
Study hypothesis
Off-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
Application has been submitted to the Scotland A Research Ethics Committee (ref: 08/MRE00/58). Approval pending as of 28/07/2008.
Study design
International multicentre open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Coronary heart disease
Intervention
This 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 type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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
Secondary outcome measures
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.
Overall trial start date
01/01/2009
Overall trial end date
24/03/2011
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
Current 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5,420 participants
Participant exclusion criteria
Current 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)
Recruitment start date
01/01/2009
Recruitment end date
24/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Clinical Trials and Research Governance
Research Services
Manor House
John Radcliffe Hospital
Headington
Oxford
OX10 7PD
United Kingdom
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research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Medical Research Council (MRC) (UK) (ref: G0700469)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25023641
Publication citations
-
Results
Rogers CA, Pike K, Campbell H, Reeves BC, Angelini GD, Gray A, Altman DG, Miller H, Wells S, Taggart DP, , Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial)., Health Technol Assess, 2014, 18, 44, v-xx, 1-157, doi: 10.3310/hta18440.