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

Sponsor
University College Cork (Other)
Overall Status
Completed
CT.gov ID
NCT01438086
Collaborator
(none)
47
Enrollment
2
Locations
3
Arms
62
Actual Duration (Months)
23.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Oct 1, 2011
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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 Names:
  • normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum glucose measurement [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) [Baseline and 8 weeks]

      Efficacy outcome measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cork University Hospital Cork Ireland
    2 Leiden University Medical Center Leiden Netherlands

    Sponsors and Collaborators

    • University College Cork

    Investigators

    • Principal Investigator: Noel Caplice, MB, PhD, University College Cork

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Noel Caplice, Professor of Cardiovascular Sciences, University College Cork
    ClinicalTrials.gov Identifier:
    NCT01438086
    Other Study ID Numbers:
    • UCC-IGF-001
    • 2011-000480-27
    First Posted:
    Sep 21, 2011
    Last Update Posted:
    Mar 30, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Professor Noel Caplice, Professor of Cardiovascular Sciences, University College Cork
    Heart Failure
    Myocardial Infarction
    Additional relevant MeSH terms:
    Heart Failure
    Myocardial Infarction
    Infarction
    Mecasermin

    Study Results

    No Results Posted as of Mar 30, 2017