Recruiting

Insulin Cardioplegia

Sponsor:

University Health Network, Toronto

Code:

NCT00188994

Conditions

Left Ventricular Dysfunction

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Insulin Cardioplegia

Study Details

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%).

Conditions

Left Ventricular Dysfunction

Study ID

NCT00188994

Start date

Aug, 1999

Status verified date

Jul, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Insulin Cardioplegia

Primary outcome measure

  • Low Output Syndrome [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Chet Jabier-Nacario, BScN

416-340-4800chet.nacario@uhn.on.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Chet Jabier-Nacario, BScN

416-340-4800chet.nacario@uhn.on.ca

Principal Investigator:

Terrence M. Yau, MD, FRCS(C)

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 29, 2005

Last verified

Jul, 2005

Keywords

  • Myocardial Protection
  • Myocardial Metabolism
  • Ventricular Function
  • Cardiovascular Disease
  • Cardioplegic Additives

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2005-12-29.