Insulin Cardioplegia for Poor Left Ventricular Function

Insulin Cardioplegia Trial for Poor Left Ventricular Function

The purpose of this investigation is to develop a means to improve the recovery of cardiac metabolism and ventricular function following coronary artery bypass surgery (CABG) in patients with poor preoperative ventricular function (e.g. ejection fraction <40%).

Study Overview

• Status: Unknown
• Conditions: Left Ventricular Dysfunction
• Intervention / Treatment: Drug: Insulin Cardioplegia

Detailed Description

Hypothesis

Insulin added to blood cardioplegia will improve the results of Coronary Artery Bypass Graft by reducing the incidence of low output syndrome (i.e., the requirement for inotropic or balloon pump assistance) in patients with a preoperative ejection fraction <40%.

• Study Type: Interventional
• Enrollment: 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • University Health Network
      • Contact: Chet Jabier-Nacario, BScN; Phone Number: 8435 416-340-4800; Email: chet.nacario@uhn.on.ca
      • Principal Investigator: Terrence M. Yau, MD, FRCS(C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has been referred for isolated coronary bypass surgery.
• LV grade 3 or 4, LVEF <40% by angio, echo, RNA.

Exclusion Criteria:

• Patient is undergoing reoperative surgery (i.e., has had any previous cardiac surgery)
• Surgeon has planned another procedure in addition to coronary bypass surgery (e.g., valve repair, replacement, ascending aorta repair or replacement, left ventricular aneurysm resection, repair of congenital defect, carotid surgery, repair of abdominal aortic aneurysm).
• Patient is scheduled for minimally invasive surgery.
• More recent assessment of LV function with LV grade 1 0r 2, LVEF>40%.
• 5 or 6 days post MI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Low Output Syndrome

Secondary Outcome Measures

Outcome Measure
Total Troponin I Release

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Terrence M. Yau, 21st Century Cardiac Surgical Society, Council on Cardiovascular and Thoracic Surgery (American Heart Association), Canadian Cardiovascular Society, Royal College of Physicians and Surgeons, Institute of Medical Sciences (University of Toronto)

Publications and helpful links

General Publications

• 1. Yau,TM, Fedak PWM, Weisel RD, Teng C, Ivanov J. Predictors of operative risk for coronary bypass operations in patients with left ventricular dysfunction. J Thorac Cardiovasc Surg 1999; 118:1006-1013. 2. RaoV, Ivanov J, Weisel RD, Ikonomidis JS, Christakis GT, David TE. Predictors of low cardiac output syndrome after coronary artery bypass. J Thorac Cardiovasc Surg 1996; 112:38-51. 3. Yau TM, Weisel RD, Mickle DAG, et al: Optimal delivery of blood cardioplegia. Circulation 1991; 84 (SAuppl II):II-380-388. 4. Yau TM, Weisel RD, Mickle DAG, et al: Alternative techniques of cardioplegia. Circulation 1992; 86(Suppl II):II-377-384. 5. Yau TM, Ikonomidis JS, Weisel RD, et al: Which techniques of cardioplegia prevent ischemia? Ann Thorac Surg 1993; 56:1020-1028. 6. Yau TM, Ikonomiodis JS, Weisel RD, et al: Ventricular function after normothermic versus hypothermic cardioplegia. J Thorac Cardiovasc Surg 1993; 105:883-844. 7. Rao V, Merante F, Weisel RD, Shirai T, Ikonomidis JS, Cohen G, Tumiati LC, Shiono N, Li RK, Mickle DAG, Robinson BH. Insulin stimulates pyruvate dehydrogenase and protects human ventricular cardiomyocytes from simulated ischemia. J Thorac Cardiovasc 1998; 116:485-94. 8. Rao V, Borger MA, Weisel RD, Ivanov J, Christakis GT, Cohen G, Yau TM,. Insulin cardioplegia for elective coronary bypass surgery. J Thorac Cardiovasc Surg 2000; 119: 1176-1184. 9. Yau TM, Mickle DAG, Weisel RD: Myocardial free radical reperfusion injury during cardiac surgery, in Kron IL, Mavroudis C (eds): Frontiers in cardiovascular surgical research: State of Art Reviews: Cardiac Surgery. Hanley & Belfus, 1990; 703-712. 10. Christakis GT, Weisel RD, Fremes SE, Ivanov J, David TE, Goldman BS, Salerno TA and the Cardiovascular Surgeons of the University of Toronto, Coronary Artery bypass grafting in patients with poor ventricular function. J Thorac Cardiovasc Surg 1992; 103:1083-1092.

Study record dates

Study Major Dates

• Study Start: August 1, 1999

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): December 29, 2005
• Last Update Submitted That Met QC Criteria: December 28, 2005
• Last Verified: July 1, 2005

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Ventricular Function; Myocardial Protection; Myocardial Metabolism; Cardioplegic Additives
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 98-E089; CIHR Grant No. HSF NA4189