Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).
Randomized, double-blind, placebo-controlled pilot study to evaluate the safety, exploratory efficacy, and pharmacokinetics of IC14 (atibuclimab) administered via a single IV infusion to patients with STEMI treated with percutaneous intervention. In additional to optional CCR2+ myocardial imaging, biomarkers, cardiac function and patient-reported outcome measures will be reported.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
monoclonal antibody against CD14
sterile normal saline for injection
Washington University School of Medicine
St Louis, Missouri, United States
University of Virginia
Charlottesville, Virginia, United States
Incidence of treatment-emergent adverse events (safety and tolerability)
Treatment-emergent adverse events
Time frame: Day 1-29
CCR2+ cell myocardial infiltration (optional)
Characterization of CCR2+ cell myocardial infiltration mean standard uptake value (SUVmean) and change from 48 hours measured by myocardial PET/CT imaging at Day 15
Time frame: 48 hours and Day 15
Biomarker C-Reactive Protein
Change from baseline
Time frame: Day 4, 15, 29
Biomarker White Blood Cell Count
Change from baseline
Time frame: Day 4, 15, and 29
Biomarker Fibrinogen
Change from baseline
Time frame: Day 4, 15, 29
Biomarker Interleukin 6
Change from baseline
Time frame: Day 4, 15, and 29
Biomarker Interleukin-1
change from baseline
Time frame: Day 4, 15, and 29
Biomarker Troponin I
change from baseline
Time frame: Day 4, 15, and 29
Single-cell RNASeq
change from baseline
Time frame: Day 4, 15, and 29
Cardiac death or readmission for heart failure
* Cardiac death defined as death due to acute MI, sudden cardiac death, HF, stroke, cardiovascular procedure, cardiovascular hemorrhage, or other cardiovascular cause. * Heart failure readmission, defined as an event in which the patient is admitted to the hospital with a primary diagnosis of HF, the length of stay is at least 24 hours (or extends over a calendar date), the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF.
Time frame: Day 1-90
Left Ventricular Ejection Fraction
Change from baseline, measured by echocardiography
Time frame: Day 1, Day 90
N-terminal pro B-type natriuretic peptide
blood test measurement of heart failure
Time frame: Day 90
New York Heart Association Class
Measurement of cardiac status
Time frame: Day 90
Kansas City Cardiomyopathy Questionnaire
Patient-reported outcome measure of health status and function
Time frame: Day 90
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