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

Heart Failure Clinical Trial

— RESUS-AMI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438086
• Other study ID #: UCC-IGF-001
• Secondary ID: 2011-000480-27
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 17, 2011
• Last updated: March 28, 2017
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Drug:
• mecasermin
Intracoronary bolus
• mecasermin
Intracoronary bolus
• 0.9% sodium chloride injection
Intracoronary bolus

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Countries where clinical trial is conducted

Ireland,  Netherlands, 

Outcome

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