Myocardial Injury following Coronary Artery bypass Surgery versus percutaneous coronary Angioplasty with stents: a randomised controlled trial using biochemical markers and cardiovascular magnetic resonance imaging

ISRCTN	ISRCTN25699844
DOI	https://doi.org/10.1186/ISRCTN25699844
Protocol serial number	06/Q1606/19
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	Cordis, a division of Johnson & Johnson Medical Ltd (UK) - Dr William van Gaal is funded by the Clinical Cardiology Research Scholarship

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Adrian Banning
Scientific

Department of Cardiology
Level 2
Headley Way
Headington
OX3 9DU
United Kingdom

Phone	+44 (0)1865 228 934
Email	adrian.banning@orh.nhs.uk

Primary study design	Interventional
Study design	Randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	MICASA
Study objectives	In patients with multivessel and/or left main Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI) compared with Coronary Artery Bypass Grafting (CABG) results in less frequent heart muscle injury, as measured by cardiac troponin I and delayed enhancement Magnetic Resonance Imaging (MRI). Secondarily, that percutaneous coronary intervention offers equivalent revascularisation compared with coronary artery bypass surgery as measured by MRI perfusion.
Ethics approval(s)	Ethics approval received from the Oxfordshire Local Research Ethics Committee on the 17th March 2006 (ref: 06/Q1606/19).
Health condition(s) or problem(s) studied	Multivessel coronary artery disease
Intervention	Coronary artery bypass grafting versus percutaneous coronary intervention.
Intervention type	Other
Primary outcome measure(s)	The frequency of new myocardial injury following PCI and CABG as assessed by biochemical markers (troponin I) and MRI.
Key secondary outcome measure(s)	1. Total amount of new myocardial necrosis (in grams) assessed by MRI 2. Change in left ventricular function assessed by MRI
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Patients with greater than or equal to two vessel CAD (greater than or equal to 50% stenosis) including the Left Anterior Descending (LAD), and/or a functionally significant left main stem stenosis of 50% or more 2. Equivalent revascularisation can be provided by PCI and CABG 3. Angina (stable or unstable), or documented silent ischaemia on functional stress testing
Key exclusion criteria	1. Contraindication to aspirin or clopidogrel 2. Women of childbearing potential 3. Non-viable myocardium in the area subtended by diseased vessels 4. Patients requiring concomitant cardiac surgery 5. Acute myocardial infarction
Date of first enrolment	01/06/2006
Date of final enrolment	31/12/2007

Department of Cardiology

Headington
OX3 9DU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No
Results article	results	08/02/2011		Yes	No
Results article	results	01/12/2011		Yes	No
Results article	results	01/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes