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

University College Cork47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Heart Failure Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serum glucose measurement

Safety outcome measure

Time frame: 30 minutes after study drug administration

Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)

Efficacy outcome measure

Time frame: Baseline and 8 weeks