Acute Coronary Syndrome Clinical Trial
Official title:
Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
Verified date | June 2012 |
Source | Universidade Positivo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 130 |
Est. completion date | December 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná | Curitiba | PR |
United States | Emory University School of Medicine | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Universidade Positivo | Emory University |
United States, Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in daily blood glucose mean concentration between treatment groups | 18 months | Yes | |
Secondary | Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC) | 18 month | Yes |
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