Clinical trial NCT01151176: Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
Official title: Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Intensive Insulin Therapy
Glucose control
Acute Coronary Syndrome
Intensive Care
Lead sponsor: Universidade Positivo
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2010-06-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Differences in daily blood glucose mean concentration between treatment groups
timeFrame: 18 months
Secondary outcomes:
measure: Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)
timeFrame: 18 month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Curitiba
country: Brazil
facility: Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná
state: PR
Study officials:
affiliation: Universidade Positivo
name: Silmara AO Leite, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Guilhermo E Umpierrez, MD
role: STUDY_CHAIR
References: