Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

When a patient has a heart attack, a blockage occurs in a coronary artery that delivers oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs. IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients will be given either a dose of mecasermin or a placebo (inactive treatment) after their coronary artery has been opened by a stent. The purpose of the study will be to evaluate the safety of the therapy and to test if the therapy will prevent or lessen heart failure by evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the heart attack.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Cork
• Treatments: Mecasermin; Mitogens

Criteria

Inclusion Criteria:

• Age 18 - 75

• Presents within 2-12 hours of at least 30 minutes of myocardial ischemic pain

• ECG evidence of myocardial infarction

• Undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction

• Left ventricular ejection fraction during PCI of 40% or less

• TIMI flow grade 3 in the infarct-related artery following reperfusion and stenting

Exclusion Criteria:

• History of prior myocardial infarction

• Prior history of heart failure, left ventricular dysfunction or cardiomyopathy

• Active or suspected neoplasia

• Known impaired liver function

• Cardiogenic shock

• Estimated glomerular filtration rate < 45 ml/min/1.73m2

• History of hypoglycaemia requiring hospitalisation

• History of primary insulin-like growth factor-1 deficiency or growth hormone disorders

• Contraindication to cardiac magnetic resonance imaging

• Pregnancy or nursing mothers

• Known allergy to study drug or any of its inactive ingredients

• Treatment with another investigational agent within 30 days of enrolment

• Subjects unable or unwilling to comply with follow-up requirements of study

• Subjects unable to provide written informed consent