Cardiac ischaemia treated with coronary artery bypass grafting Circulatory System Other acute ischaemic heart diseases
Conditions
Interventions
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 fo
Sponsors
Canberra Hospital (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia
Outcome results
None listed