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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438086
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Professor Noel Caplice, University College Cork

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
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)
Actual Study Start Date : October 2011
Actual Primary Completion Date : February 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Serum glucose measurement [ Time Frame: 30 minutes after study drug administration ]
    Safety outcome measure

  2. 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 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
Growth Substances
Physiological Effects of Drugs