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 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

September 17, 2011
March 6, 2013
October 2011
November 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01438086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Myocardial Infarction
  • Drug: mecasermin
    Intracoronary bolus
    Other Names:
    • rhIGF-1
    • IGF-1
  • Drug: 0.9% sodium chloride injection
    Intracoronary bolus
    Other Name: normal saline
  • Active Comparator: mecasermin low dose
    Intervention: Drug: mecasermin
  • Active Comparator: mecasermin high dose
    Intervention: Drug: mecasermin
  • Placebo Comparator: saline placebo
    Intervention: Drug: 0.9% sodium chloride injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
September 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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
Ireland
 
NCT01438086
UCC-IGF-001, 2011-000480-27
Yes
Professor Noel Caplice, University College Cork
University College Cork
Not Provided
Principal Investigator: Noel Caplice, MB, PhD University College Cork
University College Cork
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP