Acute Coronary Syndrome Clinical Trial
Official title:
Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in Latin America and will result in safe and better glucose control in patients with Acute Coronary Syndrome (ACS) compared with SC insulin.
The proposed study is a one center open-label randomized controlled clinical trial.Coronary
Intensive Care of one hospital in the city of Curitiba, PR, Brazil will be assessed.
Consenting eligible subjects will be randomized to either the intensive insulin infusion
therapy group (ITG) or the conventional therapy group (CTG).
This particular insulin infusion was adapted of a protocol has been used before in patients
who underwent to cardiothoracic surgery and its efficacy has been reported in the
literature.
The control group will be selected following the same set of inclusion and exclusion
criteria. Patients will be randomized to receive SC regular insulin 4 times daily (before
meals and bedtime) or every 6 hours if they are NPO .
Data will be collected for history of diabetes, heart disease ; hypertension;
hyperlipidemia; Current smoker; Cardiac treatment (Aspirin, Beta Blockers, ACE
inhibitor/A2RB, Nitrates, Statin, Fibrate) Diabetes treatment(Insulin, Metformin,
Sulphonylureas) Data will be collect for Baseline BGL , A1C level, Troponin, CPK, CKP-Mb, K,
Creatinine. Classify Infarct type : Anterior/anteroseptal, Inferior, Non-ST-segment
elevation myocardial infarction, Not classified Cardiac intervention : PTCA ,
Thrombolysis,No reperfusion, Heparin or low-molecular weight heparin.
Subjects allocated to ITG will be placed on Grady Health System protocol, and those in CTG
will follow the sliding scale nomograms. Insulin replacement will start during first 24h of
admission. Patients will be followed during all hospital stay, but only at ICU the CIII and
SC insulin replacement will be compared. After ICU discharge they will follow they will be
followed by their physician with recommendations to keep blod glucose<180mg/dL.
Patients will be followed up to 90 days after hospital discharge with phone call.Subjects
will be contacted to obtain information regarding the occurrence of cardiovascular events
following discharge. If the subject is not contactable, the next of kin and/or the subject's
general practitioner would be contacted. Where no information could be obtained, a request
will be made to the Department of Births and Deaths.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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