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02 September 2010
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| [ Print-friendly version ] |
| Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery |
| ISRCTN | ISRCTN65770930 |
| ClinicalTrials.gov identifier | |
| Public title | Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery |
| Scientific title | |
| Acronym | SCAT |
| Serial number at source | CS/2006/2267 (Sponsor's reference number) |
| Study hypothesis |
Our primary hypothesis is that by modifying the way in which combined coronary artery bypass grafting (CABG) and valve replacement surgery is carried out cardioplegic arrest time can be shortened, reperfusion injury will be reduced and functional and clinical outcome improved compared to using the conventional method of surgery.
Conventionally the heart is arrested throughout both the valvular and coronary phases of the procedure using cold blood cardioplegia. With the modified ‘hybrid’ approach the coronary surgery is carried out first on the beating heart with cardiopulmonary bypass, but without cardioplegic arrest. The heart is then arrested and the valve replacement surgery is carried out in the usual way. Please note that as of 03/07/2008 more details on the sources of funding have been added to this record (i.e., change of funding). This can be seen below in the sources of funding section. |
| Ethics approval | Ethics approval received from the NHS Southmead Research Ethics Committee on the 21st June 2006 (ref: 06/Q2002/52). |
| Study design | Parallel group, randomised controlled trial with equal allocation |
| Countries of recruitment | India, United Kingdom |
| Disease/condition/study domain | Coronary artery and valve disease |
| Participants - inclusion criteria |
1. Adults with multiple vessel coronary disease and any aortic valve disease and/or any mitral valve disease
2. Surgeons willing to carry out operation via either method |
| Participants - exclusion criteria |
1. Single vessel coronary disease
2. Marked calcific degeneration of the mitral annulus 3. Reoperation 4. Malignancy 5. Debilitating neurological disease 6. Ongoing sepsis or endocarditis 7. Carotid artery stenosis greater than 75% 8. Critical limb ischaemia 9. Emergency operation for unstable angina 10. Salvage procedures |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/10/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 160 |
| Interventions |
Patients will be prepared for surgery and anaesthetised according to standard protocols. Moderate hypothermic cardiopulmonary bypass (CPB) (32°C) will be used in all patients.
For the ‘hybrid’ group, following establishment of CPB, left ventricular venting will be conventionally achieved through the right superior pulmonary vein. CPB mean arterial pressure will be maintained at 75 mmHg to optimise myocardial perfusion of the empty beating heart during coronary surgery. Coronary grafting will be according to our reported method for beating heart coronary surgery. For both groups cardioplegic arrest will be achieved with cold (4 - 6°C) intermittent antegrade and retrograde blood cardioplegia. In the conventional surgery group the heart will be arrested throughout the operation. For the ‘hybrid’ group cardioplegic arrest will be instituted after completion of the coronary surgery. |
| Primary outcome measure(s) | The primary outcome will be the composite endpoint of death, postoperative myocardial infarction, arrhythmia, requirement for pacing for more than 12 hours and/or inotropic support for more than 12 hours. |
| Secondary outcome measure(s) |
1. Clinical measures:
1.1. Duration of cardiopulmonary bypass 1.2. Duration of aortic cross clamp 1.3. Low cardiac output (LCO) 1.4. Blood loss 1.5. Transfusion requirement 1.6. Intubation time 1.7. Chest or wound infection 1.8. Any subsystem organ complication 1.9. Intensive Care Unit (ICU) and hospital stay 2. Metabolic stress: metabolites extracted from myocardial biopsies from the apex of the left ventricle will include adenine nucleotides and related compounds as well as amino acids (alanine/glutamate ratio) and lactate 3. Reperfusion injury: serum concentrations of troponin I will be determined prior to surgery, and at 1, 4, 12, 24, 48 and 72 hours post-operatively |
| Sources of funding |
Added as of 03/07/2008:
National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre Programme |
| Trial website | |
| Publications | |
| Contact name | Dr Raimondo Ascione |
| Address |
Bristol Heart Institute
University of Bristol Level 7, Bristol Royal Infirmary Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Tel | +44 (0)117 928 3145 |
| Fax | +44 (0)117 929 9737 |
| r.ascione@bristol.ac.uk | |
| Sponsor | United Bristol NHS Healthcare Trust (UK) |
| Address |
UBHT Research and Effectiveness Department
Bristol Royal Infirmary Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| Tel | +44 (0)117 928 3473 |
| debbie.mcphee@ubht.nhs.uk | |
| Sponsor website: | http://www.ubht.nhs.uk |
| Date applied | 20/04/2007 |
| Last edited | 14/08/2008 |
| Date ISRCTN assigned | 13/06/2007 |
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