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|Status||Condition||Sponsor/Collaborator(s)||First Received||Last Changed||Verification Date|
|Completed||Myocardial Reperfusion Injury; Cardiac Output; Low||University Hospital Birmingham
collaborator(s): University of Birmingham; Brighton and Sussex University Hospitals NHS Trust; British Heart Foundation
|February 17, 2009||May 19, 2010||May 2010|
|Study Type||Study Design||Phase||Enrollment||Start Date||End Date|
|Interventional||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment||Phase 2/Phase 3||290||February 2007||-|
|University Hospital Birmingham||Birmingham West Midlands B15 2TH United Kingdom||-||-||-||-|
|Brighton & Sussex University Hospitals NHS Trust||Brighton West Sussex BN2 5BE United Kingdom||-||-||-||-|
|Drug||Perhexiline||Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.|
|Drug||Placebo marked PEXSIG||Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.|
|Type||Measure||Time Frame||Safety Issue|
|Primary||Incidence of Low Cardiac Output Syndrome||6 hours post-removal of aortic X-clamp||No|
|Secondary||Increase in Cardiac index of greater than or equal to 0.3 L/min/m2||6 hours post-removal of aortic X-clamp||No|
|Secondary||Incidence of inotropes use according to protocol||6 and 12 hours post-removal of aortic X-clamp||No|
|Secondary||Peak and total release of Troponin||6, 12 and 24 hours post-release of aortic X-clamp||No|
Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery
|Gender||Minimum Age||Maximum Age||Healthy Volunteers|
- Isolated coronary artery bypass surgery
- Diabetes Mellitus
- Renal impairment with Creatinine greater than or equal to 200micromol/L
- Atrial fibrillation
- Amiodarone therapy, recent (in last month) or current
- Hepatic impairment, significant preoperative
- Peripheral neuropathy
- Pregnancy or breast-feeding
- Emergency surgery or required on clinical grounds within 5 days of referral
PMID 16399292: Quinn DW, Pagano D, Bonser RS, Rooney SJ, Graham TR, Wilson IC, Keogh BE, Townend JN, Lewis ME, Nightingale P; Study Investigators. Improved myocardial protection during coronary artery surgery with glucose-insulin-potassium: a randomized controlled trial. J Thorac Cardiovasc Surg. 2006 Jan;131(1):34-42.
PMID 16820580: Ranasinghe AM, Quinn DW, Pagano D, Edwards N, Faroqui M, Graham TR, Keogh BE, Mascaro J, Riddington DW, Rooney SJ, Townend JN, Wilson IC, Bonser RS. Glucose-insulin-potassium and tri-iodothyronine individually improve hemodynamic performance and are associated with reduced troponin I release after on-pump coronary artery bypass grafting. Circulation. 2006 Jul 4;114(1 Suppl):I245-50.
PMID 17445089: Ashrafian H, Horowitz JD, Frenneaux MP. Perhexiline. Cardiovasc Drug Rev. 2007 Spring;25(1):76-97. Review.