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| [ ...Back to search results ] | [ Print-friendly version ] |
| Coronary artery grafting in high risk patients randomised to off-pump or on-pump surgery |
| ISRCTN | ISRCTN29161170 |
| ClinicalTrials.gov identifier | |
| Public title | Coronary artery grafting in high risk patients randomised to off-pump or on-pump surgery |
| Scientific title | |
| Acronym | CRISP |
| Serial number at source | MRC ref: G0700469 |
| 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 MRC Research Portfolio: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700469&CaseId=9693 Please note that as of 05/03/10 the inclusion and exclusion criteria of this trial have been updated. All updates can be found in the relevant field with the above update date. |
| Lay summary | |
| 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 |
| Countries of recruitment | United Kingdom, International |
| Disease/condition/study domain | Coronary heart disease |
| Participants - inclusion criteria |
Current information as of 05/03/10:
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 |
| Participants - exclusion criteria |
Current information as of 05/03/10:
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) |
| Anticipated start date | 01/01/2009 |
| Anticipated end date | 01/01/2011 |
| Status of trial | Stopped |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 5,420 participants (in recruitment until 24/03/2011) |
| Interventions |
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. |
| 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 |
| 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. |
| Sources of funding | Medical Research Council (MRC) (UK) (ref: G0700469) |
| Trial website | |
| Publications | |
| Contact name | Prof David Taggart |
| Address |
Nuffield Department of Surgery
University of Oxford John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| david.taggart@orh.nhs.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance
Research Services Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX10 7PD |
| Country | United Kingdom |
| research.services@admin.ox.ac.uk | |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 28/07/2008 |
| Last edited | 31/03/2011 |
| Date ISRCTN assigned | 31/10/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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