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

This study has been completed.
Information provided by (Responsible Party):
Professor Noel Caplice, University College Cork Identifier:
First received: September 17, 2011
Last updated: March 28, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Heart Failure Myocardial Infarction Drug: mecasermin Drug: 0.9% sodium chloride injection Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Professor Noel Caplice, University College Cork:

Primary Outcome Measures:
  • 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

Enrollment: 47
Actual Study Start Date: October 2011
Study Completion Date: December 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mecasermin low dose Drug: mecasermin
Intracoronary bolus
Other Names:
  • rhIGF-1
  • IGF-1
Active Comparator: mecasermin high dose Drug: mecasermin
Intracoronary bolus
Other Names:
  • rhIGF-1
  • IGF-1
Placebo Comparator: saline placebo Drug: 0.9% sodium chloride injection
Intracoronary bolus
Other Name: normal saline


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01438086

Cork University Hospital
Cork, Ireland
Leiden University Medical Center
Leiden, Netherlands
Sponsors and Collaborators
University College Cork
Principal Investigator: Noel Caplice, MB, PhD University College Cork
  More Information

Responsible Party: Professor Noel Caplice, Professor of Cardiovascular Sciences, University College Cork Identifier: NCT01438086     History of Changes
Other Study ID Numbers: UCC-IGF-001
2011-000480-27 ( EudraCT Number )
Study First Received: September 17, 2011
Last Updated: March 28, 2017

Keywords provided by Professor Noel Caplice, University College Cork:
Heart Failure
Myocardial Infarction

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017