Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction (VCU-Alpha1RT)
Acute myocardial infarction is characterized by an intense inflammatory response.
The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction|
- C reactive protein [ Time Frame: 14 days ] [ Designated as safety issue: No ]Area under the curve for C reactive protein (CRP) drawn at admission, 3 days and 14 days
- Left ventricular end-systolic volume change [ Time Frame: 3 months ] [ Designated as safety issue: No ]We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography
- Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.
|Study Start Date:||December 2013|
|Study Completion Date:||July 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Alpha-1 anti-trypsin (AAT)
We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
Drug: Alpha 1-Antitrypsin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01936896
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Antonio Abbate, MD, PhD||Virginia Commonwealth University|
|Principal Investigator:||Benjamin Van Tassell, PharmD||Virginia Commonwealth University|