Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction

Study Overview
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Brief Summary
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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).

Official Title
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Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Alpha 1-Antitrypsin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new Planned or completed coronary angiogram for potential intervention Age>21 Exclusion Criteria: Inability to give informed consent Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump) Pregnancy Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV) Preexisting severe left ventricular dysfunction (EF<20%) Preexisting severe valvular heart disease Known active infections (acute or chronic) Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only) Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) Known active malignancy of any type, or prior diagnosis in the past 10 years Anticipated need for cardiac or major surgery Known active cancer (or prior diagnosis of cancer within the past 10 years) Known Immunoglobulin A (IgA) deficiency

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha-1 anti-trypsin (AAT)<br>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<br> <br> * Other names: Aralast NP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C Reactive Protein (Area Under the Curve) | A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular End-systolic Volume Change | We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Heart Failure, Inflammation