Condition category
Circulatory System
Date applied
28/07/2008
Date assigned
31/10/2008
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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
-
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
-
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK) (ref: G0700469)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes