Surgical Treatment for Ischaemic Heart Failure Trial (STICH)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2800

Inclusion Criteria

1. Men
2. Women who are not of childbearing potential
3. Aged 18 years or above
4. Who have a left ventricular ejection fraction (LVEF) less than 0.35 measured by cardiac magnetic resonance (CMR) ventriculogram, gated single photon emission computed tomography (SPECT) ventriculogram, echocardiography, or contrast ventriculogram within three months of trial entry
5. Who have coronary artery disease suitable for revascularisation

Exclusion Criteria

1. Failure to provide informed consent
2. Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement
3. Cardiogenic shock (within 72 hours of randomization) as defined by the need for intra-aortic balloon support or the requirement for intravenous inotropic support
4. Plan for percutaneous intervention of coronary artery disease
5. Recent acute myocardial infarction judged to be an important cause of left ventricular dysfunction
6. History of more than one prior coronary bypass operation
7. Non-cardiac illness with a life expectancy of less than 3 years
8. Non-cardiac illness imposing substantial operative mortality
9. Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode)
10. Previous heart, kidney, liver, or lung transplantation
11. Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device

MED Therapy Eligibility Criteria:
12. Absence of left main coronary artery disease as defined by an intraluminal stenosis of 50% or greater
13. Absence of Canadian Class III angina or greater (angina markedly limiting ordinary activity)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CABG combined with MED compared to MED alone, measured up to 6 years.

Secondary Outcome Measures

Name	Time	Method
Measured up to 6 years:<br>1. Cardiac magnetic resonance (CMR) of left ventricle (LV) shape, size and function for predicting the benefit of a specific treatment strategy<br>2. Nuclear cardiology and/or echocardiography testing of myocardial ischaemia