A Phase 2 Pilot Study to Evaluate the Safety and Activity of BB3 as an Adjunct to Percutaneous Coronary Intervention (PCI) in Subjects Presenting With Acute ST Segment Elevation Myocardial Infarction (STEMI)
Overview
- Phase
- Phase 2
- Intervention
- BB3
- Conditions
- Myocardial Infarction
- Sponsor
- Angion Biomedica Corp
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Evaluation of Reduction in Infarct Size
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function following myocardial infarction (heart attack).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided and signed written informed consent, approved by the Institutional Review Board (IRB), prior to performance of any study related procedure including screening procedure.
- •Subject is male or female
- •Subject is 21 to 80 years of age
- •Estimated body weight \< 120 kg and BMI \< 40
- •Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) (e.g., chest pain, arm pain, etc.,) \>30 minutes duration and unresponsive to nitroglycerin; with ST segment elevation of more than 1 mm in at least two contiguous leads of ECG or new or presumed new onset bundle branch block (BBB)
- •Fulfills clinical center's criteria for primary PCI
- •PCI will be done within 12 hours of onset of STEMI.
- •The subject and his/her physician are willing to comply with the requirements of the study and the specified follow-up evaluations.
- •If female, either surgically sterile or post-menopausal or using acceptable contraception and agree to use effective birth control regimen during the study period. Men must agree to use condoms during the study period. Women of child bearing potential must have a negative urine or serum pregnancy test.
- •In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.
Exclusion Criteria
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 6 months following index procedure.
- •Cardiogenic shock (Killip class 4) or cardiac arrest
- •History of prior myocardial infarction or pre-existing Q waves on ECG
- •An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first six months post enrollment;
- •Any contraindication to undergo MRI imaging. This will include any of the following exclusions:
- •Cardiac pacemaker or implantable defibrillator;
- •Non-MRI-compatible aneurysm clip;
- •Neural stimulator (e.g., TENS-Unit);
- •Any implanted or magnetically activated device (e.g., insulin pump);
- •Any type of non-MRI-compatible metallic ear implant;
Arms & Interventions
BB3
Daily intravenous administration of 2 mg/kg BB3 for four (4) days
Intervention: BB3
Normal Saline
Daily intravenous administration for four (4) days
Intervention: Normal saline
Outcomes
Primary Outcomes
Evaluation of Reduction in Infarct Size
Time Frame: 6 month
Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage
Evaluation of the Degree of Late Ventricular Remodeling
Time Frame: 6 months
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).
Secondary Outcomes
- Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain(1 and 6 months)
- LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography(6 months)
- Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography(1 and 6 months)
- Change in CK-MB and Troponin(6 months)
- Change in BNP Levels(6 months)
- Change in Symptoms and Clinical Signs of CHF(6 months)
- Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)(6 months)
- Frequency of MACE(6 months)
- Frequency of New Onset CHF Through 6 Months(6 months)
- Number of Hospitalizations for CHF Through 6 Months(6 months)
- Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram(6 months)
- Frequency of AE, SAEs(6 months)
- Frequency of MACCE(6 months)
- All-cause Mortality(6 months)
- Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia(6 months)
- Change From Baseline eCrCl(6 months)
- Change in Body Weight(6 months)
- Symptoms and Clinical Signs of CHF(6 months)