Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients
Information source: Saint Luke's Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglycemia; Acute Coronary Syndromes; Myocardial Infarction
Intervention: Exenatide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Saint Luke's Health System Official(s) and/or principal investigator(s): Steven P Marso, MD, Principal Investigator, Affiliation: Mid America Heart Institute Saint Luke's Health System
Summary
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in
hyperglycemic patients admitted to the coronary intensive care unit.
Clinical Details
Official title: Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Median Glucose Values From Steady State Through 48 Hours or Until Discharge.Time to Steady State
Secondary outcome: Rates of Hypoglycemia and Severe HypoglycemiaSerious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)
Detailed description:
Diabetic patients with acute myocardial infarction (MI) have particularly poor outcomes.
Clinical practice guidelines from the American College of Cardiology/American Heart
Association for the treatment of patients with acute coronary syndromes call for treatment
to achieve preprandial glucose <110 mg/dL, a maximum daily target <180 mg/dL, and a
post-discharge hemoglobin A1c <7%. Initiation of aggressive insulin therapy is also
warranted to achieve blood glucose <150 mg/dL during days 0-3 and 80-110 mg/dL when possible
thereafter. To date, no studies have been conducted assessing the efficacy of intravenous
exenatide administration on achieving glucose lowering in hyperglycemic coronary ICU
patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Admission to coronary ICU
- Admission blood glucose 140-299 mg/dL
- Primary cardiovascular diagnosis by attending physician
- Under primary care of cardiology service
- Age > 18 years old
- Ventilator independent
- Able to provide informed consent
Exclusion Criteria:
- Admission blood glucose < 140 or > 300 mg/dL
- Ventilator dependent
- Unconscious sedation
- Type 1 diabetes
- Known pregnancy
- Admitted to coronary ICU for right heart cath to measure hemodynamics prior to
transplant
- Post transplant procedure
- Currently enrolled in another clinical trial
- Unable to provide informed consent
- Creatinine clearance < 30 mL/min
- On insulin treatment except for monotherapy with long-acting basal insulin (e. g.,
insulin glargine [LantusĀ®] or detemir [LevemirĀ®])
- Gastroparesis
Locations and Contacts
Mid America Heart Institute Saint Luke's Health System, Kansas City, Missouri 64111, United States
Additional Information
Starting date: August 2008
Last updated: November 19, 2014
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