Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
26-6-2009V1
Study information
Scientific title
Cardioprotection by Riluzole in Cardiac Bypass Surgery: A randomised double-blind placebo-controlled trial
Acronym
R-Cardiac
Study hypothesis
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.
Ethics approval
Australian Capital Territory Human Research Ethics Committee (ACTHEC) approved on the 12th of March 2010 (ref: ETH7.09.711)
Study design
Single centre randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Cardiac ischaemia treated with coronary artery bypass grafting
Intervention
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.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
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).
Secondary outcome measures
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
Overall trial start date
01/07/2010
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
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
Recruitment start date
01/07/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Australia
Trial participating centre
Canberra Orthopaedic Group
Deakin
2600
Australia
Funders
Funder type
Hospital/treatment centre
Funder name
Canberra Hospital (Australia) - Trauma and Orthopaedic Research Unit (internal funding)
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