|
ISRCTN
|
ISRCTN25699844
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
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
|
|
Scientific title
|
|
|
Acronym
|
MICASA
|
|
Serial number at source
|
06/Q1606/19
|
|
Study hypothesis
|
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.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Ethics approval received from the Oxfordshire Local Research Ethics Committee on the 17th March 2006 (ref: 06/Q1606/19).
|
|
Study design
|
Randomised clinical trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Multivessel coronary artery disease
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/06/2006
|
|
Anticipated end date
|
31/12/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
60
|
|
Interventions
|
Coronary artery bypass grafting versus percutaneous coronary intervention.
|
|
Primary outcome measure(s)
|
The frequency of new myocardial injury following PCI and CABG as assessed by biochemical markers (troponin I) and MRI.
|
|
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
|
|
Sources of funding
|
Cordis, a division of Johnson & Johnson Medical Ltd (UK) - Dr William van Gaal is funded by the Clinical Cardiology Research Scholarship
|
|
Trial website
|
|
|
Publications
|
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21205592
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21292125
|
|
Contact name
|
Dr
Adrian
Banning
|
|
Address
|
Department of Cardiology
Level 2
Headley Way
|
|
City/town
|
Headington
|
|
Zip/Postcode
|
OX3 9DU
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1865 228 934
|
|
Fax
|
+44 (0)1865 220 585
|
|
Email
|
adrian.banning@orh.nhs.uk
|
|
Sponsor
|
Oxford Radcliffe Hospitals NHS Trust (UK)
|
|
Address
|
Research and Development
Manor House
John Radcliffe Hospital
Headley Way
|
|
City/town
|
Headington
|
|
Zip/Postcode
|
OX3 9DU
|
|
Country
|
United Kingdom
|
|
Date applied
|
23/04/2006
|
|
Last edited
|
01/11/2011
|
|
Date ISRCTN assigned
|
06/06/2006
|
