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

Study Overview
=================
Brief 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.

Official Title
-----------------
A Randomised Trial Evaluating the Safety and Efficacy of a Single Low Dose of Intracoronary Insulin-like Growth Factor-1 Following Percutaneous Coronary Intervention for ST-Elevation Acute Myocardial Infarction (RESUS-AMI)

Conditions
-----------------
Heart Failure, Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: mecasermin
* Drug: mecasermin
* Drug: 0.9% sodium chloride injection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mecasermin low dose<br> | Drug: mecasermin<br>* Intracoronary bolus<br>* Other names: IGF-1;|
| Active Comparator: mecasermin high dose<br> | Drug: mecasermin<br>* Intracoronary bolus<br>* Other names: IGF-1;|
| Placebo Comparator: saline placebo<br> | Drug: 0.9% sodium chloride injection<br>* Intracoronary bolus<br>* Other names: normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum glucose measurement | Safety outcome measure | 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 | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Myocardial Infarction