Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

Condition(s) targeted: Acute Coronary Syndrome

Intervention: Regular Insulin (Drug); Regular Insulin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Universidade Positivo

Official(s) and/or principal investigator(s):
Silmara AO Leite, PhD, MD, Principal Investigator, Affiliation: Universidade Positivo
Guilhermo E Umpierrez, MD, Study Chair, Affiliation: Emory University

Overall contact:
Silmara AO Leite, PhD, Phone: 55 41 9963 4932, Email: siaol@uol.com.br

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.

Official title: Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Differences in daily blood glucose mean concentration between treatment groups

Secondary outcome: evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)

Detailed description: The proposed study is a multicenter open-label randomized controlled clinical trial. Coronary Intensive Care of two hospitals 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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female

- Age 18 or older

- Evidence of AMI within the last 24 h (troponin-T >0. 1mcg/l) or electrographic

criteria of ST-segment elevation in two limb leads)

- Evidence of Unstable Angina

- Blood glucose >180mg/dL at admission with or without preexisting diabetes

- Willing to give informed consent

- Access to telephone communications after hospital discharge

Exclusion Criteria:

- Under 18 years of age

- Pregnant or lactating female

- Diabetes ketoacidosis

- Heart failure

- Cardiogenic shock

Silmara AO Leite, PhD, Phone: 55 41 9963 4932, Email: siaol@uol.com.br

Emory University School of Medicine, Atlanta, Georgia 30303, United States; Active, not recruiting

Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná, Curitiba, PR 80420-011, Brazil; Recruiting
Eliana F Reynaldo, PH, Phone: 55 41 9236 8553, Email: laboratorio@cruzvermelhapr.br
Silmara AO Leite, MD, PhD, Principal Investigator
Giuseppe Facin, MD, Sub-Investigator

Hospital VITA-Batel, Curitiba, PR 80420-160, Brazil; Recruiting
Luciana Moraes, MD, Phone: 55 41 9995 9927, Email: lunmoraes@yahoo.com.br
Luciana Moraes, MD, Sub-Investigator

Starting date: January 2010
Last updated: October 18, 2010