Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction (VCU-Alpha1RT)

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Myocardial Infarction

Treatments: Drug: Alpha 1-Antitrypsin

Study type: Interventional

Funder types: Other

Identifiers

NCT01936896

HM15342

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Alpha-1 anti-trypsin (AAT)

Experimental group

Description:

We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)

Treatment:

Drug: Alpha 1-Antitrypsin