Shortening cardioplegic arrest time during combined coronary and valvular surgery

ISRCTN	ISRCTN65770930
DOI	https://doi.org/10.1186/ISRCTN65770930
Protocol serial number	CS/2006/2267 (Sponsor's reference number)
Sponsor	United Bristol NHS Healthcare Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre Programme

Submission date: 20/04/2007
Registration date: 13/06/2007
Last edited: 27/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Raimondo Ascione
Scientific

Bristol Heart Institute
University of Bristol
Level 7, Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3145
Email	r.ascione@bristol.ac.uk

Study information

Primary study design	Interventional
Study design	Parallel-group randomised controlled trial with equal allocation
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery
Study acronym	SCAT
Study objectives	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.
Ethics approval(s)	NHS Southmead Research Ethics Committee, 21/06/2006, ref: 06/Q2002/52
Health condition(s) or problem(s) studied	Coronary artery and valve disease
Intervention	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.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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.
Key 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
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	160
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

United Kingdom
England
India

Study participating centre

Bristol Heart Institute

Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/08/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/04/2017: Publication reference added.