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ISRCTN
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ISRCTN30506717
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ClinicalTrials.gov identifier
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Public title
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Cardioprotection by Riluzole in Cardiac Bypass Surgery
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Scientific title
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Cardioprotection by Riluzole in Cardiac Bypass Surgery: A randomised double-blind placebo-controlled trial
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Acronym
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R-Cardiac
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Serial number at source
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26-6-2009V1
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Study hypothesis
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The primary aim of this study is to analyse the effect of Riluzole in preventing myocardial damage post cardiac bypass surgery (CABG).
The primary null hypothesis of this study is that Riluzole treatment will have no effect on myocardial damage post CABG as determined by Troponin rise post surgery.
The secondary aims of this study are to observe the effect of Riluzole on the incidence of atrial and ventricular arrhythmias post CABG and on cardiac function as assessed by transthoracic echocardiography.
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Lay summary
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Ethics approval
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Australian Capital Territory Human Research Ethics Committee (ACTHEC) approved on the 12th of March 2010 (ref: ETH7.09.711)
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Study design
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Single centre randomised double blind placebo controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Cardiac ischaemia treated with coronary artery bypass grafting
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Participants - inclusion criteria
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1. Participant aged 18 to 75 years of age, either sex
2. Ischaemic heart disease planned for CABG.
3. Participant has anaesthesia risk (ASA) score of 4 or less
4. Provision of informed consent
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Participants - exclusion criteria
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1. Patients who are unable to give informed consent (e.g. poor English language skills)
2. Patients who are to undergo simultaneous valvular surgery in addition to CABG
3. Premenopausal females (Riluzole has not been proven safe in the setting of pregnancy)
4. Patients with an implantable cardiac defibrillator or cardiac pacemaker in situ
5. Patients with existing atrial fibrillation
6. Patients with significant pre-existing hepatic impairment (hepatic enzymes greater than 2x upper normal range)
7. Emergency CABG surgery
8. CABG for other than 2-4 vessels
9. Patients with severe renal failure on dialysis
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Anticipated start date
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01/07/2010
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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48
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Interventions
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Clinical trial of Riluzole v placebo, before and following coronary artery bypass surgery.
1. Riluzole oral 100mg / day for 5 pre-operative days, 200mg immediately pre-surgery, and 100mg for 5 days following surgery.
2. Riluzole oral 100mg / day for 5 pre-operative days, 200mg immediately pre-surgery, and placebo (potato starch, identical capsule) for 5 days following surgery.
3. Placebo (potato starch, identical capsule) oral each day for 5 pre-operative days, and for 5 days following surgery.
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Primary outcome measure(s)
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Troponin levels post CABG. Measured at 2, 3, 6, 8, 12, 24, 48, 72, 96 and 120 hours post surgery in order to calculate the Troponin rise curve. The assay is cTropnin I in plasma (ng/ml).
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Secondary outcome measure(s)
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1. Incidence of cardiac arrhythmia post CABG. 12 lead ECG will be collected pre op, during surgery and ECG during ICU. Thence patients will wear a holter monitor until discharge home. Repeat 12 lead ECG will be conducted at 6 weeks follow up.
2. Incidence of abnormal findings on echo cardiography. Pre-admission echocardiography will be compared to post operative, Day 4 and 6 weeks echo.
3. Cardiac function will be assessed in all patients using transthoracic echocardiography at baseline and post surgery prior to discharge from hospital. Cardiac parameters will be measured off-line using commercially available software (EchoPac 6.0.1, GE Healthcare). The following parameters will be derived:
3.1. Left ventricular (LV) posterior and septal wall thickness and LV mass
3.2. LV relaxation and filling pressure by Doppler-echo for assessment of diastolic function
3.3. LV ejection fraction
3.4. Left atrial (LA), right ventricular (RV) and LV regional myocardial function by 2D-speckle tracking methods
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Sources of funding
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Canberra Hospital (Australia) - Trauma and Orthopaedic Research Unit (internal funding)
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Trial website
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Publications
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Contact name
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Prof
Paul
Smith
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Address
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Canberra Orthopaedic Group
Clinical Services Building
173 Strickland Crescent
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City/town
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Deakin
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Zip/Postcode
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2600
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Country
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Australia
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Sponsor
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Canberra Hospital (Australia)
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Address
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General Manager
Executive offices
Building 2, Level 3
PO Box 11
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City/town
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Woden
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Zip/Postcode
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2606
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Country
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Australia
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Date applied
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08/06/2010
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Last edited
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28/06/2010
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Date ISRCTN assigned
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28/06/2010
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