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Insulin Cardioplegia for Poor Left Ventricular Function

Primary Purpose

Left Ventricular Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Insulin Cardioplegia
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Dysfunction focused on measuring Myocardial Protection, Myocardial Metabolism, Ventricular Function, Cardiovascular Disease, Cardioplegic Additives

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Health NetworkRecruiting

Outcomes

Primary Outcome Measures

Low Output Syndrome

Secondary Outcome Measures

Total Troponin I Release

Full Information

First Posted
September 13, 2005
Last Updated
December 28, 2005
Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00188994
Brief Title
Insulin Cardioplegia for Poor Left Ventricular Function
Official Title
Insulin Cardioplegia Trial for Poor Left Ventricular Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

Brief Summary
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%).
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction
Keywords
Myocardial Protection, Myocardial Metabolism, Ventricular Function, Cardiovascular Disease, Cardioplegic Additives

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Insulin Cardioplegia
Primary Outcome Measure Information:
Title
Low Output Syndrome
Secondary Outcome Measure Information:
Title
Total Troponin I Release

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chet Jabier-Nacario, BScN
Phone
416-340-4800
Ext
8435
Email
chet.nacario@uhn.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence M. Yau
Organizational Affiliation
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)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chet Jabier-Nacario, BScN
Phone
416-340-4800
Ext
8435
Email
chet.nacario@uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Terrence M. Yau, MD, FRCS(C)

12. IPD Sharing Statement

Citations:
Citation
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.
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Insulin Cardioplegia for Poor Left Ventricular Function

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