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Safety and Feasibility of the Injectable BL-1040 Implant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by:
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT00557531
First received: November 12, 2007
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility of the Injectable BL-1040 Implant

Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BL-1040 Device: BL-1040
2 mL of BL-1040

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557531

Locations
Germany
Heidelberg University MC
Heidelberg, Germany
Sponsors and Collaborators
BioLineRx, Ltd.
Sheba Medical Center
Investigators
Principal Investigator: Paul Vermeersch, MD Antwerp MC
  More Information

No publications provided

Responsible Party: BioLineRx, Public Company
ClinicalTrials.gov Identifier: NCT00557531     History of Changes
Other Study ID Numbers: 1040.01, 1040.01
Study First Received: November 12, 2007
Last Updated: February 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013