Coronary Disease, Myocardial Infarction, Myocardial Ischemia
Conditions
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Revascularization
Brief summary
The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.
Interventions
DRUGFX06
400 mg as intravenous injection in two divided boluses
PROCEDUREPercutaneous coronary intervention
Sponsors
Fibrex Medical Research & Development GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have given informed consent * Patients after primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI) * Men or women with no child bearing potential * Onset of symptoms to balloon time \< 6 hours * ST-elevation of at least 2 mm in at least 3 leads on 12-lead electrocardiogram (ECG) * Primary PCI indicated per standard of care * First myocardial infarction (MI) * Single index lesion with complete occlusion \[thrombolysis in myocardial infarction (TIMI) flow 0/I\] of one target vessel.
Exclusion criteria
* History of MI (from patient history, or from ECG) * Chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the acute myocardial infarction (AMI) * Need for coronary artery bypass graft (CABG) * Administration of any thrombolytic agent since onset of AMI symptoms * Serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, LM dissection, etc.) * Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents * Contraindication to cardiovascular magnetic resonance (CMR): claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; frequent extrasystoles (\> 12/Min) or atrial fibrillation (AF). * Known renal dysfunction defined as serum creatinine \> 250 µmol/l * Previous CABG * History of congestive heart failure (CHF) * Body mass index (BMI) \> 35 * Patients who cannot communicate reliably with the investigator * Patients who are unlikely to cooperate with the requirements of the study * Patients who are unwilling and/or unable to give informed consent * Patients at increased risk of death from a pre-existing concurrent illness * Patients participating in another clinical study * Patients who have used any other investigational drugs within 1 month of first dosing * Patients who have participated already in this study * Patients who are employees at the investigational site; relatives or spouse of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infarct size as measured by cardiac MRI | 5-7 days post intervention |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial scar mass and left ventricular function | 4 months post intervention |
Countries
Austria, Belgium, Czechia, Denmark, Germany, Lithuania, Netherlands, Poland, Romania, Sweden, Switzerland
Outcome results
None listed