Clinical trial NCT01438086: Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Myocardial Infarction
Keywords: Heart Failure
Myocardial Infarction
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Serum glucose measurement
timeFrame: 30 minutes after study drug administration
measure: Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: University College Cork
name: Noel Caplice, MB, PhD
role: PRINCIPAL_INVESTIGATOR
References: