Acute Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, Heart Failure, Inflammation
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).
Interventions
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C Reactive Protein (Area Under the Curve) | 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
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular End-systolic Volume Change | 3 months | We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 3 months | We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alpha-1 Anti-trypsin (AAT) Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI) | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Alpha-1 Anti-trypsin (AAT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 52.5 years |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
C Reactive Protein (Area Under the Curve)
A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alpha-1 Anti-trypsin (AAT) | C Reactive Protein (Area Under the Curve) | 75.9 mg/L |
Secondary
Left Ventricular End-systolic Volume Change
We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography
Time frame: 3 months
Population: Only 5 patients had paired (i.e. baseline and 3 months) echocardiograms for evaluation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alpha-1 Anti-trypsin (AAT) | Left Ventricular End-systolic Volume Change | 2 mL |
Other Pre-specified
Safety
We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.
Time frame: 3 months