Cardioprotection by Riluzole in Cardiac Bypass Surgery

ISRCTN	ISRCTN30506717
DOI	https://doi.org/10.1186/ISRCTN30506717
Secondary identifying numbers	26-6-2009V1

Submission date: 08/06/2010
Registration date: 28/06/2010
Last edited: 28/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Smith
Scientific

Canberra Orthopaedic Group
Clinical Services Building
173 Strickland Crescent
Deakin
2600
Australia

Study information

Study design	Single centre randomised double blind placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Cardioprotection by Riluzole in Cardiac Bypass Surgery: A randomised double-blind placebo-controlled trial
Study acronym	R-Cardiac
Study objectives	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(s)	Australian Capital Territory Human Research Ethics Committee (ACTHEC) approved on the 12th of March 2010 (ref: ETH7.09.711)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2010
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	48
Key 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
Key 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
Date of first enrolment	01/07/2010
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

Australia

Study participating centre

Canberra Orthopaedic Group

Deakin
2600
Australia

Sponsor information

Canberra Hospital (Australia)
Hospital/treatment centre

General Manager
Executive offices
Building 2, Level 3
PO Box 11
Woden
2606
Australia

"ROR"	https://ror.org/04h7nbn38

Funders

Funder type

Hospital/treatment centre

Canberra Hospital (Australia) - Trauma and Orthopaedic Research Unit (internal funding)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan