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

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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01438086

Acronym

RESUS-AMI

Enrollment

Registered

2011-09-21

Start date

2011-10-31

Completion date

2016-12-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Myocardial Infarction

Keywords

Heart Failure, Myocardial Infarction

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.

Interventions

DRUGmecasermin

Intracoronary bolus

DRUG0.9% sodium chloride injection

Intracoronary bolus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Ireland, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026