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

Overview

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).

Full Title of Study: “Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • Drug: Alpha 1-Antitrypsin

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • C Reactive Protein (Area Under the Curve)
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antonio Abbate, MD, PhD, Principal Investigator, Virginia Commonwealth University
    • Benjamin Van Tassell, PharmD, Principal Investigator, Virginia Commonwealth University

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