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

Phase 1

Completed

• Conditions: Heart Failure; Myocardial Infarction
• Interventions: Drug: mecasermin; Drug: 0.9% sodium chloride injection

• Registration Number: NCT01438086
• Lead Sponsor: University College Cork

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-17
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Study Start: 2011-10
• Primary Completion: 2016-02
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mecasermin low dose	mecasermin	-
saline placebo	0.9% sodium chloride injection	-
mecasermin high dose	mecasermin	-

Primary Outcome Measures

Name	Time	Method
Serum glucose measurement	30 minutes after study drug administration	Safety outcome measure
Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)	Baseline and 8 weeks	Efficacy outcome measure

Trial Locations

Locations (2)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Cork University Hospital; 🇮🇪 Cork, Ireland