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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by University College Cork
Information provided by (Responsible Party):
Professor Noel Caplice, University College Cork
ClinicalTrials.gov Identifier:
First received: September 17, 2011
Last updated: July 11, 2015
Last verified: July 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University College Cork:

Primary Outcome Measures:
  • Serum glucose measurement [ Time Frame: 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Efficacy outcome measure

Estimated Enrollment: 51
Study Start Date: October 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (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
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438086

Contact: Mary C De Voe, RN +1 202-684-5467 mcdevoe@gmail.com
Contact: Prof. Noel Caplice, MB, PhD +353 21 4901442 n.caplice@ucc.ie

Cork University Hospital Recruiting
Cork, Ireland
Contact: Janet Choi, RgN    +353 85 1143890      
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Mary C De Voe, RN         
Contact       mcdevoe@gmail.com   
Principal Investigator: Douwe E. Atsma, MD, PhD         
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
ClinicalTrials.gov Identifier: NCT01438086     History of Changes
Other Study ID Numbers: UCC-IGF-001  2011-000480-27 
Study First Received: September 17, 2011
Last Updated: July 11, 2015
Health Authority: Ireland: Health Products Regulatory Authority

Keywords provided by University College Cork:
Heart Failure
Myocardial Infarction

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016