Safety and Feasibility of the Injectable BL-1040 Implant
This trial is active, not recruiting.
|Phase||phase 1/phase 2|
|Collaborator||Sheba Medical Center|
|Start date||March 2008|
|End date||January 2010|
|Trial size||30 participants|
|Trial identifier||NCT00557531, 1040.01|
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.
|Intervention model||single group assignment|
Occurrence of all AEs including but not limited to All MIs CV hospitalization Serious ventricular arrhythmias sustained: Symptomatic heart failure Renal failure Stroke Death
time frame: 6 months
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
time frame: 6 months
Male or female participants from 18 years up to 75 years old.
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
|Official title||Safety and Feasibility of the Injectable BL-1040 Implant|
|Principal investigator||Paul Vermeersch, MD|
|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|
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