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Sponsors and Collaborators: |
BioLineRx, Ltd. Sheba Medical Center |
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Information provided by: | BioLineRx, Ltd. |
ClinicalTrials.gov Identifier: | NCT00557531 |
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.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Disease |
Device: BL-1040 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Safety and Feasibility of the Injectable BL-1040 Implant |
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BL-1040: Experimental |
Device: BL-1040
2 mL of BL-1040
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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
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
One or more of the following:
Exclusion Criteria:
Contact: Leor Johnathan, MD | 97235348685 | leorj@tau.ac.il |
Germany | |
Heidelberg University MC | Recruiting |
Heidelberg, Germany | |
Contact: Mark Rosenberg, MD Mark.Rosenberg@med.uni-heidelberg.de |
Principal Investigator: | Paul Vermeersch, MD | Antwerp MC |
Responsible Party: | Public Company ( BioLineRx ) |
Study ID Numbers: | 1040.01, 1040.01 |
Study First Received: | November 12, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00557531 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Cardiovascular Diseases |