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Sponsors and Collaborators: |
Saint Luke's Health System Amylin Pharmaceuticals, Inc. |
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Information provided by: | Saint Luke's Health System |
ClinicalTrials.gov Identifier: | NCT00736229 |
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.
Condition | Intervention | Phase |
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Acute Coronary Syndromes Hyperglycemia Myocardial Infarction |
Drug: Exenatide |
Phase IV |
Study Type: | Interventional |
Study Design: | Efficacy Study, Non-Randomized, Open Label, Single Group Assignment, Treatment |
Official Title: | Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Exenatide: Experimental |
Drug: Exenatide
0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cheryl Rutherford, RN | 816-932-2000 ext 6275 | cjrutherford@saint-lukes.org |
Contact: Kathryn Safley, RN | 816-932-2000 ext 9885 | ksafley@saint-lukes.org |
United States, Missouri | |
Mid America Heart Institute Saint Luke's Health System | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Contact: Cheryl Rutherford, RN 816-932-2000 ext 6275 cjrutherford@saint-lukes.org | |
Principal Investigator: Steve Marso, MD |
Responsible Party: | Mid America Heart Institute Saint Lukes' Health System ( Steven P. Marso, MD ) |
Study ID Numbers: | 08-206 |
Study First Received: | August 14, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00736229 History of Changes |
Health Authority: | United States: Institutional Review Board |
acute coronary syndromes hyperglycemia myocardial infarction |
Metabolic Diseases Heart Diseases Exenatide Myocardial Ischemia Vascular Diseases Ischemia Necrosis |
Hypoglycemic Agents Hyperglycemia Acute Coronary Syndrome Infarction Glucose Metabolism Disorders Myocardial Infarction Metabolic Disorder |
Disease Metabolic Diseases Heart Diseases Exenatide Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Ischemia Pharmacologic Actions Necrosis |
Hypoglycemic Agents Hyperglycemia Pathologic Processes Syndrome Acute Coronary Syndrome Cardiovascular Diseases Infarction Glucose Metabolism Disorders Myocardial Infarction |