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

Phase 1

Completed

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Alpha-1 anti-trypsin (AAT)	Alpha 1-Antitrypsin	We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)

Primary Outcome Measures

Name	Time	Method
C Reactive Protein (Area Under the Curve)	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.

Secondary Outcome Measures

Name	Time	Method
Left Ventricular End-systolic Volume Change	3 months	We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography