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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 is currently recruiting participants.
Verified March 2013 by University College Cork
Sponsor:
Information provided by (Responsible Party):
Professor Noel Caplice, University College Cork
ClinicalTrials.gov Identifier:
NCT01438086
First received: September 17, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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: 45
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: November 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438086

Contacts
Contact: Mary C De Voe, RN 202-684-5467 mcdevoe@gmail.com
Contact: Prof. Noel Caplice, MB, PhD +353-21-490-1442 n.caplice@ucc.ie

Locations
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Contact: Janet Choi, RgN     +353-85-1143890        
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Noel Caplice, MB, PhD University College Cork
  More Information

No publications provided

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: March 6, 2013
Health Authority: Ireland: Irish Medicines Board

Keywords provided by University College Cork:
Heart Failure
Myocardial Infarction

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

ClinicalTrials.gov processed this record on May 19, 2013