Clinical Trial: Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery
Brief Summary: Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.
Detailed Summary:
Sponsor: University Hospital Birmingham
Current Primary Outcome: Incidence of Low Cardiac Output Syndrome [ Time Frame: 6 hours post-removal of aortic X-clamp ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Increase in Cardiac index of greater than or equal to 0.3 L/min/m2 [ Time Frame: 6 hours post-removal of aortic X-clamp ]
- Incidence of inotropes use according to protocol [ Time Frame: 6 and 12 hours post-removal of aortic X-clamp ]
- Peak and total release of Troponin [ Time Frame: 6, 12 and 24 hours post-release of aortic X-clamp ]
Original Secondary Outcome: Same as current
Information By: University Hospital Birmingham
Dates:
Date Received: February 17, 2009
Date Started: February 2007
Date Completion:
Last Updated: May 19, 2010
Last Verified: May 2010
