ST Elevation Myocardial Infarction MedDRA version: 17.1 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Increlex
Pharmaceutical Form: Injection
INN or Proposed INN: MECASERMIN
CAS Number: 68562-41-4
Concentration unit: ng nanogram(s)
Concentration type: equal
Concentration number: 1.5-
Pharm
Sponsors
University College Cork
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 – 75 2. Subject presents to hospital within 2-12 hours of the onset of myocardial ischemic pain of at least 30 minutes duration 3. Twelve-lead electrocardiogram reveals one of the following: ST-segment elevation * 0.1 mV in two or more limb leads, or * 0.2 mV in two or more contiguous precordial leads indicative of acute myocardial infarction, or left bundle-branch block 4. Undergoing percutaneous coronary intervention (PCI) for ST elevation myocardial infarction 5. Left ventricular ejection fraction during PCI =65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. History of prior myocardial infarction 2. Prior history of heart failure, left ventricular dysfunction or cardiomyopathy 3. Active or suspected neoplasia 4. Known impaired liver function 5. Cardiogenic shock 6. Estimated glomerular filtration rate < 45 ml/min/1.73m2 7. History of hypoglycaemia requiring hospitalisation 8. History of primary insulin growth factor-1 deficiency or growth hormone disorders including acromegaly 9. Contraindication to cardiac MRI 10. Pregnancy (for women of childbearing potential, have a negative pregnancy test at screening) or nursing mothers 11. Known allergy to study drug or any of its inactive ingredients 12. Treatment with another investigational agent within 30 days of enrolment 13. Subjects unable or unwilling to comply with follow-up requirements of study 14. Subjects unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study will be to evaluate two low doses of a single intracoronary injection of rhIGF-1 compared with saline placebo on global left ventricular (LV) ejection fraction by cardiac magnetic resonance imaging and for safety (hypoglycaemia) in select subjects with ST elevation myocardial infarction and severe LV dysfunction undergoing percutaneous coronary intervention.;Secondary Objective: The secondary efficacy objectives are to compare the effects of two doses of rhIGF-1 to placebo with respect to: - Regional left ventricular (LV) wall motion and thickness by cardiac MRI - LV mass, LV end-systolic volumes, LV end-diastolic volumes, LV stroke volume, Regional wall motion abnormalities and cardiac output - Infarct size - New York Heart Association class The secondary safety objectives are to assess the safety profile of an intracoronary single low dose of rhIGF-1 with respect to: - Incidence of hypotension or arrhythmias at time of study drug administration - Incidence of clinical events: cardiovascular and all-cause death, recurrent myocardial infarction, severe recurrent ischemia, TVR, hospitalisation for worsening HF, stroke and arrhythmia - Treatment-related Adverse Events - Incidence of abnormal clinical laboratory measurements ;Primary end point(s): The primary efficacy endpoint is percent change from baseline in global LVEF at 8 weeks measured by quantitative cardiac MRI The primary safety endpoint to be measured is serum glucose measurement obtained 30 minutes and 1 hour after study drug administration ;Timepoint(s) of evaluation of this end point: Percent change from baseline in global LVEF will be measured at 8 weeks The primary safety endpoint of serum glucose will be measured 30 minutes and 1 hour after study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: - Change from baseline in regional left ventricular (LV) wall motion and thickness at Week 8 by cardiac MRI - Change from baseline in LV mass, LV end-systolic volumes, LV end-diastolic volumes, LV stroke volume and cardiac output (by cardiac MRI and echocardiography) at Week 8 - Change from baseline in infarct size at Week 8 - NYHA class at Week 8, Month 6 and Month 12 - Change from baseline in left ventricular ejection fraction (LVEF), LV end-systolic volumes, LV end-diastolic volumes, and regional wall motion abnormality (RWMA) at Month 6 and Month 12 The secondary safety endpoints are: - Incidence of hypotension or arrhythmias at time of study drug administration - Incidence of clinical events: cardiovascular and all-cause death, recurrent myocardial infarction, severe recurrent ischemia, target vessel revascularisation, hospitalisation for worsening heart failure, stroke and arrhythmia through month 12 - Treatment-related adverse events - Incidence of abnormal clinical laboratory measurements through hospitalisation for index event;Timepoint(s) of evaluation of this end point: Efficacy: - Regional LV wall motion and thickness and infarct size at Week 8 - LV mass, LV end-systolic and diastolic volumes, LV stroke volume and cardiac output at Week 8 - NYHA class at Week 8, Month 6 and Month 12 - LVEF, LV end-systolic and diastolic volumes and RWMA at Months 6 & 12 Safety: - Incidence of hypotension or arrhythmias are recorded at time of study drug administration - Incidence of clinical events is continuous through Month 12 - Treatment-related adverse events are collected throughout trial (through Month 12) - Incidence of abnormal clinical laboratory measurements are collected throughout hospitalisation for index event | — |
Countries
Ireland, Netherlands
Contacts
Public ContactProf. Noel Caplice
University College Cork
Outcome results
None listed