Cardiovascular Disease
Conditions
Brief summary
This is a Phase I, multi-center, open label study designed to assess the safety and feasibility of the injectable BL-1040 implant to provide scaffolding to infarcted myocardial tissue.
Detailed description
ENDPOINTS Preliminary safety endpoints Occurrence of all adverse events including but not limited to All MIs Cardiovascular hospitalization Serious ventricular arrhythmias sustained: VT (symptomatic or sustained VT \[duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse\]) VF symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block Symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) Renal failure Stroke Death Secondary safety endpoints Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP
Interventions
DEVICEBL-1040
2 mL of BL-1040
Sponsors
Sheba Medical Center
BioLineRx, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * 18 to 75 years of age, inclusive * Male or female * Negative pregnancy test for women of child-bearing potential, or surgically sterile, or post menopausal * Acute MI defined as: * Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: * Ischemic symptoms; * Development of pathologic Qwaves on the ECG; * ECG changes indicative of ischemia (ST segment elevation or depression) * First anterior or inferolateral STEMI or Qwave MI (QMI Anterior: V1-V3 or V1-V4 or V1-V5 or V1-V6.QMI Inferior: L2, L3, AVF, or L2, L3, AVF+ V5, V6 or L2, L3, AVF+ V6-V9 \[posterior leads\]) * Regional wall motion score index (at least 4 out of 16 akinetic segments) * One or more of the following: * LVEF \>20% and \<45% measured and calculated by 2-dimensional measurement * Biomarkers: peak CK \> 2000 IU * Infarct size \> 25% as measured by MRI * Successful revascularization with PCI with 1 stent only, within 7 days of the index MI * At time of application of study device, patient must have patent infarct related artery (IRA) and TIMI flow grade = 3
Exclusion criteria
* History of CHF, Class I to Class IV, as per NYHA criteria * History of prior LV dysfunction * At time of application of study device - Killip III-IV (pulmonary edema, cardiogenic shock - hypotension systolic \< 90 mmHg and evidence of peripheral hypoperfusion oliguria, cyanosis, sweating) or HR \> 100 bpm * Prior CABG * Prior MI * History of stroke * Significant valvular disease (moderate or severe) * Patient is a candidate for CABG or PCI on non-IRA * Patient is being considered for CRT within the next 30 days * Renal insufficiency (eGFR \< 60) * Chronic liver disease (\> 3 times upper limit of normal) * Life expectancy \< 12 months * Current participant in another clinical trial, or participation in another trial within the last 6 months * Any contraindication to coronary angiography, MRI or PCI procedures * Patient taking anti-coagulation medication prior to MI * Pregnant or lactating women; pregnancy confirmed by urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of all AEs including but not limited to All MIs CV hospitalization Serious ventricular arrhythmias sustained: Symptomatic heart failure Renal failure Stroke Death | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index) Change from baseline in regional (infarct related) and global wall motion score Change from baseline in ejection fraction Cardiac rupture NT-proBNP | 6 months |
Countries
Germany
Outcome results
None listed