Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction (VCU-Alpha1RT)
|ClinicalTrials.gov Identifier: NCT01936896|
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Alpha 1-Antitrypsin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2014|
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
- C Reactive Protein (Area Under the Curve) [ Time Frame: 14 days ]A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.
- Left Ventricular End-systolic Volume Change [ Time Frame: 3 months ]We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography
- Safety [ Time Frame: 3 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|