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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cork University Hospital, Cork, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mecasermin

Drug

Intracoronary bolus

Other names: rhIGF-1, IGF-1

0.9% sodium chloride injection

Drug

Intracoronary bolus

Other names: normal saline

Primary outcomes

Serum glucose measurement

Time frame: 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)

Time frame: Baseline and 8 weeks

Efficacy outcome measure

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study 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)

Acronym: RESUS-AMI

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Sep 21, 2011
Registry last updated: Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed