Clinical trial NCT01936896: Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
Official title: Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Heart Failure
Inflammation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: C Reactive Protein (Area Under the Curve)
timeFrame: 14 days
Secondary outcomes:
measure: Left Ventricular End-systolic Volume Change
timeFrame: 3 months
Other outcomes:
measure: Safety
timeFrame: 3 months
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Antonio Abbate, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Benjamin Van Tassell, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abouzaki NA, Christopher S, Trankle C, Van Tassell BW, Carbone S, Mauro AG, Buckley L, Toldo S, Abbate A. Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-alpha1RT Study. J Cardiovasc Pharmacol. 2018 Jun;71(6):375-379. doi: 10.1097/FJC.0000000000000583.