Phase 2
N=10
Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01936896 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Feb 2016
Primary outcome: Primary: C Reactive Protein (Area Under the Curve) — 75.9 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alpha 1-Antitrypsin (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C Reactive Protein (Area Under the Curve) |
75.9 | — |
| SECONDARY Left Ventricular End-systolic Volume Change |
2 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01936896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.