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

Completed · Phase 1/Phase 2

Conditions studied: Acute Myocardial Infarction

In brief

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).

Key facts

Study ID

NCT01936896

Run by

Virginia Commonwealth University

People needed

10

Starts

2013-12-01

Expected to finish

2014-07-01

Last updated by the study team

2016-02-12

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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