This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).
This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI. Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. We will assess the ability of exenatide to reduce ischemic injury. This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
Foothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGRoyal Alexandra Hospital
Edmonton, Alberta, Canada
RECRUITINGRatio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)
Time frame: 3 months
Left ventricular global and regional LV systolic ejection fraction
Time frame: 72 hours
Left ventricular global and regional LV systolic ejection fraction
Time frame: 3 months
Left ventricular volume
Time frame: 72 hours
Left ventricular volume
Time frame: 3 months
Infarct size/area of risk (measured by cMRI)
Time frame: 3 months
Myocardial enzyme levels (troponin I and CK-MB)
Time frame: 24 hours
ST segment elevation resolution (measured by ECG)
Time frame: 1 hour
ST segment elevation resolution (measured by ECG)
Time frame: 24 hours
ST segment elevation resolution (measured by ECG)
Time frame: 72 hours
ST segment elevation resolution (measured by ECG)
Time frame: 3 months
Angiographic myocardial blush score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alberta Hospital
Edmonton, Alberta, Canada
RECRUITINGHamilton Health Sciences - General Site
Hamilton, Ontario, Canada
RECRUITINGLondon Health Sciences Centre
London, Ontario, Canada
RECRUITINGSouthlake Regional Health Centre
Newmarket, Ontario, Canada
RECRUITINGSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGSt. Michael's Hospital
Toronto, Ontario, Canada
RECRUITINGToronto General Hospital, University Health Network
Toronto, Ontario, Canada
RECRUITINGInstitut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval)
Québec, Quebec, Canada
RECRUITINGTime frame: At the time of the PCI procedure
Serum glucose concentration
Time frame: Baseline
Serum glucose concentration
Time frame: 8 hours
Serum glucose concentration
Time frame: 16 hours
Serum glucose concentration
Time frame: 24 hours
Serum glucose concentration
Time frame: 72 hours
Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)
Time frame: 24 hours
NT-proBNP blood levels
Time frame: 24 hours
Death
Time frame: 3 months
Myocardial infarction (heart attack)
Time frame: 3 months
Measure of extent of heart failure (NYHA classification)
Time frame: 72 hours
Measure of extent of heart failure (NYHA classification)
Time frame: 3 months
Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)
Time frame: 6 months
Death
Time frame: 6 months
Recurrent myocardial infarction (heart attack)
Time frame: 6 months
Stroke
Time frame: 6 months
Unplanned repeat revascularization
Time frame: 6 months
Development of heart failure
Time frame: 6 months
Cardiogenic shock
Time frame: During index hospitalization (up to 6 months)
Blood glucose < 3.0 mmol/L
Time frame: During index hospitalization (up to 6 months)
Hypotension (defined as SBP <90 mmHg)
Time frame: During index hospitalization (up to 6 months)