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ISRCTN
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ISRCTN86284615
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DOI
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10.1186/ISRCTN86284615
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Heart failure revascularisation
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9900791
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Study hypothesis
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To determine whether coronary revascularisation, improves the survival of patients with heart failure due to coronary disease who have evidence of dysfunctional but viable myocardium or stress-induced ischaemia (but who do not require revascularisation for the relief of angina) and who are receiving optimal medical treatment.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Heart failure with left ventricular systolic dysfunction
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Participants - inclusion criteria
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1. Heart failure (in the investigators' opinion) with left ventricular systolic dysfunction (ejection fraction less than 35%) requiring chronic diuretic therapy
2. Coronary disease as the cause of heart failure as evidenced by a history of previous myocardial infarction, previous revascularisation or previous angiography
3. Stress-induced myocardial ischaemia or evidence of myocardial hibernation/stunning affecting five or more left ventricular segments in a 16-segment model. The core laboratories will make the decision about whether the test identifies a sufficient volume of affected myocardium
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Participants - exclusion criteria
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1. Patients who are not candidates for Coronary Artery Bypass Graft (CABG) because of frailty or serious co-morbidity (eg:- severe lung disease, metastatic carcinoma)
2. Unstable angina, myocardial infarction or stroke within the preceding two months
3. Inability to give written informed consent
4. Unwilling to consent to being contacted directly by staff at the data centre or unwilling to allow their hospital notes to be copied and sent to the data centre
5. Patients being considered for revascularisation for the relief of chest pain (angina) or valve surgery
6. Patients involved in another randomised controlled trial
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Anticipated start date
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01/01/2002
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Anticipated end date
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30/09/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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800
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Interventions
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Best medical therapy versus best medical therapy and revascularisation
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Primary outcome measure(s)
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All-cause mortality
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Secondary outcome measure(s)
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1. All-cause mortality or myocardial infarction more than 72 hours from coronary revascularisation
2. All-cause mortality and all-cause hospitalisation
3. All-cause mortality and unplanned cardiovascular hospitalisation
4. Days alive and out of hospital
5. Death, non-fatal myocardial infarction or non-fatal stroke
6. Symptom scores for angina and heart failure
7. Quality of life (using EuroHeart Failure, EQ-5D and Minnesota Living with Heart Failure Questionnaires)
8. Mean cost of Therapy (a health economic outcome)
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Sources of funding
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Initial funding provided by the Medical Research Council (UK).
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Trial website
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Publications
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1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12798827
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21156659
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Contact name
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Professor
John GF
Cleland
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Address
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Academic Unit of Cardiology
University of Hull
Castle Hill Hospital
Cottingham
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City/town
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Kingston-upon-Hull
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Zip/Postcode
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HU16 5TX
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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18/10/2000
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Last edited
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16/05/2011
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Date ISRCTN assigned
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18/10/2000
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