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Insulin Cardioplegia for Poor Left Ventricular Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188994
First received: September 13, 2005
Last updated: December 28, 2005
Last verified: July 2005
History of Changes
  Purpose

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%).


Condition Intervention
Left Ventricular Dysfunction
 Drug: Insulin Cardioplegia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Insulin Cardioplegia Trial for Poor Left Ventricular Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Low Output Syndrome

Secondary Outcome Measures:
  • Total Troponin I Release

Estimated Enrollment: 800
Study Start Date: August 1999
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%.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188994

Contacts
Contact: Chet Jabier-Nacario, BScN 416-340-4800 ext 8435 chet.nacario@uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Chet Jabier-Nacario, BScN     416-340-4800 ext 8435     chet.nacario@uhn.on.ca    
Principal Investigator: Terrence M. Yau, MD, FRCS(C)            
Sponsors and Collaborators
University Health Network, Toronto
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)
  More Information

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.

ClinicalTrials.gov Identifier: NCT00188994     History of Changes
Other Study ID Numbers: 98-E089, CIHR Grant No. HSF NA4189
Study First Received: September 13, 2005
Last Updated: December 28, 2005
Health Authority: "Canada: University Health Network REB"

Keywords provided by University Health Network, Toronto:
Myocardial Protection
Myocardial Metabolism
Ventricular Function
Cardiovascular Disease
Cardioplegic Additives

Additional relevant MeSH terms:
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013