Condition category
Circulatory System
Date applied
23/04/2006
Date assigned
06/06/2006
Last edited
24/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adrian Banning

ORCID ID

Contact details

Department of Cardiology
Level 2
Headley Way
Headington
OX3 9DU
United Kingdom
+44 (0)1865 228 934
adrian.banning@orh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/Q1606/19

Study information

Scientific title

Acronym

MICASA

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multivessel coronary artery disease

Intervention

Coronary artery bypass grafting versus percutaneous coronary intervention.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The frequency of new myocardial injury following PCI and CABG as assessed by biochemical markers (troponin I) and MRI.

Secondary outcome measures

1. Total amount of new myocardial necrosis (in grams) assessed by MRI
2. Change in left ventricular function assessed by MRI

Overall trial start date

01/06/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiology
Headington
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Research and Development
Manor House
John Radcliffe Hospital
Headley Way
Headington
OX3 9DU
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Cordis, a division of Johnson & Johnson Medical Ltd (UK) - Dr William van Gaal is funded by the Clinical Cardiology Research Scholarship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21205592
2. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21292125
3. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21908890
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23696598

Publication citations

  1. Results

    van Gaal WJ, Arnold JR, Testa L, Karamitsos T, Lim CC, Ponnuthurai FA, Petersen S, Francis JM, Selvanayagam J, Sayeed R, West N, Westaby S, Neubauer S, Banning AP, Myocardial injury following coronary artery surgery versus angioplasty (MICASA): a randomised trial using biochemical markers and cardiac magnetic resonance imaging., EuroIntervention, 2011, 6, 6, 703-710, doi: 10.4244/EIJV6I6A119.

  2. Results

    Lim CC, van Gaal WJ, Testa L, Cuculi F, Arnold JR, Karamitsos T, Francis JM, Petersen SE, Digby JE, Westaby S, Antoniades C, Kharbanda RK, Burrell LM, Neubauer S, Banning AP, With the "universal definition," measurement of creatine kinase-myocardial band rather than troponin allows more accurate diagnosis of periprocedural necrosis and infarction after coronary intervention., J. Am. Coll. Cardiol., 2011, 57, 6, 653-661, doi: 10.1016/j.jacc.2010.07.058.

  3. Results

    Cuculi F, Lim CC, van Gaal W, Testa L, Westaby S, Arnold JR, Neubauer S, Banning AP, Systemic levels of endothelin correlate with systemic inflammation and not with myocardial injury or left ventricular ejection fraction in patients undergoing percutaneous coronary intervention and on-pump coronary artery bypass grafting., Interact Cardiovasc Thorac Surg, 2011, 13, 6, 585-589, doi: 10.1510/icvts.2011.278192.

  4. Results

    Arnold JR, Karamitsos TD, van Gaal WJ, Testa L, Francis JM, Bhamra-Ariza P, Ali A, Selvanayagam JB, Westaby S, Sayeed R, Jerosch-Herold M, Neubauer S, Banning AP, Residual ischemia after revascularization in multivessel coronary artery disease: insights from measurement of absolute myocardial blood flow using magnetic resonance imaging compared with angiographic assessment., Circ Cardiovasc Interv, 2013, 6, 3, 237-245, doi: 10.1161/CIRCINTERVENTIONS.112.000064.

Additional files

Editorial Notes