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

ISRCTN	ISRCTN29161170
DOI	https://doi.org/10.1186/ISRCTN29161170
Secondary identifying numbers	MRC 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

Email	david.taggart@orh.nhs.uk

Study information

Study design	International multicentre open randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Coronary artery grafting in high risk patients randomised to off-pump or on-pump surgery
Study acronym	CRISP
Study objectives	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(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) studied	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
Primary outcome measure	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 study start date	01/01/2009
Completion date	24/03/2011
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	5,420 participants
Key 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
Key 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)
Date of first enrolment	01/01/2009
Date of final enrolment	24/03/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Research Services
Manor House
John Radcliffe Hospital
Headington
Oxford
OX10 7PD
England
United Kingdom

Email	research.services@admin.ox.ac.uk
Website	http://www.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Medical Research Council (MRC) (UK) (ref: G0700469)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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