Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery

Inclusion Criteria:

1. Subjects must be 18 to 85 years of age
2. Subject is scheduled to undergo CABG surgery with cardiopulmonary bypass

3. Subjects at an increased risk for I/R mediated tissue damage: defined as subjects with ≥ 30% but ≤ 50% ejection fraction (as measured by echocardiography within 14 days of study enrollment) or who fulfill at least two of the following criteria:

   • Current or recent smoker (within last 6 months prior to screening)
   • Female
   • Diabetes mellitus (a history of diabetes, regardless of duration of disease or need for anti-diabetic agents)
   • History of non-disabling stroke, TIA, carotid endarterectomy
   • Re- CABG (H/O previous CABG surgery, on or off-pump)
   • Peripheral artery surgery or angioplasty
   • Recent MI (≥ 48 hours and ≤ 6 weeks before surgery, non STEMI and STEMI infarcts as documented in the medical records of the subject)
   • History of congestive heart failure (NYHA CHF Class III or IV)
   • Renal dysfunction: creatinine clearance ≥ 30mL/min but < 60mL/min calculated using Crockroft and Gault formula: Creatinine clearance (mL/min) = (140 - age) x weight (kg) (x 0.85 for females) (72 x serum creatinine)
   • Asymptomatic stenosis (≥ 50%) in ≥ 1 carotid artery
   • Age > 65 years

Exclusion Criteria:

1. Known sulfite allergy or sulphur drug allergy
2. Subjects who have received treatment for asthma within the past 12 months
3. Myocardial infarction occurring < 48 hours prior to surgery
4. Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture, or papillary muscle rupture
5. History of prior disabling stroke
6. Clinically relevant liver disease (defined as serum transaminases ≥ 3 x upper limit of normal for local laboratory)
7. Poorly controlled diabetes mellitus (defined as HbA1c > 9.0%)
8. Planned concomitant cardiac valve or other surgery at time of CABG
9. Planned use of thiopental during anesthesia for CABG surgery
10. All females of child bearing potential (defined as having menses without an alternative medical cause during the last 12 months). Women who are pregnant (defined as a positive serum pregnancy test), breast-feeding or lactating are also excluded.
11. Ongoing alcohol or drug abuse
12. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
13. Subject has participated in another investigational drug or device study within 30 days prior to enrollment to the study.