Primary Outcomes: Difference in the change in wall motion score index between admission, day 3-5 and after 3 months in the two treatment arms.
Secondary Outcomes: Changes in inflammatory/endothelial markers and myocardial perfusion from admission, day 3-5 and after 3 months between the two treatment arms.
Researchers will randomise patients with acute myocardial infarction and blood glucose levels (BGLs) >=10mmol/L within 24 hours of pain onset, to either tight glucose control (aiming BGLs 4.5 – 7mmol/L) with an insulin infusion (for 24 hours) followed by subcutaneous insulin or standard control (BGL 6 – 12mmol/L) without the use of an insulin infusion. Serial myocardial contrast echocardiography will measure changes in myocardial perfusion and function from baseline to 3 months between each group. We will also measure changes in inflammatory and endothelial markers over this time to see whether tight glucose control improves these surrogate endpoints.
Official Title
Impact of Tight Glycaemic Control With Insulin on Novel Vascular Disease Risk Factors and Myocardial Function and Perfusion in Acute Myocardial Infarction Patients With Hyperglycaemia
Conditions
Study Type
Interventional
Study Design
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Study Start
Eligibility & Criteria
Ages Eligible for Study: 18 Years and aboveGenders Eligible for Study: Both CriteriaInclusion Criteria:- Age >=18years – Acute Myocardial Infarction – Blood Glucose Level >=10mmol/L – Wall motion abnormality on baseline echocardiogram Exclusion Criteria:- Active infection/inflammation – Cardiac shunt – Cognitive Impairment – Insulin allergy
Total Enrolment
40
Contact Details
Australia, VictoriaThe Royal Melbourne Hospital, Melbourne, Victoria, 3050, Australia; Recruiting Leo Rando, MBBS FRACP +61 3 9342 7365 leo.rando@mh.org.au Peter Colman, MD FRACP + 61 3 9342 7365 peter.colman@mh.org.au
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