The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function following myocardial infarction (heart attack).
Percutaneous coronary intervention (PCI) has become the mainstay for treatment of ST-segment elevation myocardial infarction (STEMI). Whereas early recanalization undoubtedly salvages myocardial tissue, reperfusion following prolonged ischemia can also exacerbate injury. Infarct size needs to be limited, and the conditions favoring adaptive ventricular healing and remodeling optimized because in patients with acute myocardial infarction (AMI) who do not die of out-of-hospital arrhythmias, long-term prognosis is dependent on the amount of myocardium that is lost, and the outcome of ventricular remodeling. Angion Biomedical Corp. has identified BB3, a small molecule mimetic of hepatocyte growth factor/scatter factor (HGF/SF) whose activity is expected to preserve tissue viability and attenuate dysfunction in the setting of organ injury while obviating the logistical difficulties associated with gene or protein therapy. HGF/SF is a naturally occurring cell survival factor that holds significant therapeutic potential. BB3 has been shown to possess HGF/SF activities, including protection against heart injury following myocardial infarction. This study is designed to evaluate clinical efficacy of BB3 in patients presenting with acute ST segment elevation myocardial infarction (A-STEMI) who undergo PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
Daily intravenous administration of 2 mg/kg BB3 for four (4) days
Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Yale University Medical Center
New Haven, New York, United States
Evaluation of Reduction in Infarct Size
Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage
Time frame: 6 month
Evaluation of the Degree of Late Ventricular Remodeling
Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).
Time frame: 6 months
Change in CK-MB and Troponin
Time frame: 6 months
Change in BNP Levels
Time frame: 6 months
Change in Symptoms and Clinical Signs of CHF
Time frame: 6 months
Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)
Time frame: 6 months
LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography
Time frame: 6 months
Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography
Time frame: 1 and 6 months
Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain
Time frame: 1 and 6 months
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Frequency of MACE
Time frame: 6 months
Frequency of New Onset CHF Through 6 Months
Time frame: 6 months
Number of Hospitalizations for CHF Through 6 Months
Time frame: 6 months
Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram
Time frame: 6 months
Frequency of AE, SAEs
Time frame: 6 months
Frequency of MACCE
Time frame: 6 months
All-cause Mortality
Time frame: 6 months
Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia
Time frame: 6 months
Change From Baseline eCrCl
Time frame: 6 months
Change in Body Weight
Time frame: 6 months
Symptoms and Clinical Signs of CHF
Symptoms and clinical signs of CHF measured by NYHA classification
Time frame: 6 months