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| Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN65770930 |
| Date ISRCTN assigned | 13/06/2007 |
| Local reference number(s) | CS/2006/2267 (Sponsor's reference number) |
| Public title | Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery |
| Scientific title | |
| Acronym | SCAT |
| Disease/condition/study domain | Coronary artery and valve disease |
| 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. |
| Design/methodology | Parallel group, randomised controlled trial with equal allocation to the two treatment groups. |
| Research ethics review | NHS Southmead Research Ethics Committee, approved on 21 June 2006 (ref: 06/Q2002/52) |
| Countries of trial | United Kingdom (from the outset), India (to join later). |
| 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 >75% 8. Critical limb ischaemia 9. Emergency operation for unstable angina 10. Salvage procedures |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/10/2010 |
| Status of trial | Ongoing |
| Target number of participants | 160 |
| Interventions | Patients will be prepared for surgery and anaesthetized 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 postoperatively. |
| Sources of funding | Sources of funding not yet confirmed as of 23 April 2007. |
| Sponsor name | United Bristol NHS Healthcare Trust (UK) |
| Sponsor details | UBHT Research and Effectiveness Department Bristol Royal Infirmary Marlborough Street Bristol United Kingdom BS2 8HW |
| Sponsor telephone | +44 (0)117 928 3473 |
| Sponsor email | debbie.mcphee@ubht.nhs.uk |
| Sponsor website | http://www.ubht.nhs.uk |
| Contact name | Dr Raimondo Ascione |
| Contact details | Bristol Heart Institute University of Bristol Level 7, Bristol Royal Infirmary Marlborough Street Bristol United Kingdom BS2 8HW |
| Contact telephone | +44 (0)117 928 3145 |
| Contact fax | +44 (0)117 929 9737 |
| Contact email | r.ascione@bristol.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN65770930 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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