Clinical trial NCT00557531: Safety and Feasibility of the Injectable BL-1040 Implant
Official title: Safety and Feasibility of the Injectable BL-1040 Implant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cardiovascular Disease
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2007-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Occurrence of all AEs including but not limited to All MIs CV hospitalization Serious ventricular arrhythmias sustained: Symptomatic heart failure Renal failure Stroke Death
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University MC
Study officials:
affiliation: Antwerp MC
name: Paul Vermeersch, MD
role: PRINCIPAL_INVESTIGATOR
References: