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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)

Primary Purpose

Heart Failure, Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
mecasermin
mecasermin
0.9% sodium chloride injection
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cork University Hospital
  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

mecasermin low dose

mecasermin high dose

saline placebo

Arm Description

Outcomes

Primary Outcome Measures

Serum glucose measurement
Safety outcome measure
Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)
Efficacy outcome measure

Secondary Outcome Measures

Full Information

First Posted
September 17, 2011
Last Updated
March 28, 2017
Sponsor
University College Cork
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1. Study Identification

Unique Protocol Identification Number
NCT01438086
Brief Title
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
Acronym
RESUS-AMI
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction
Keywords
Heart Failure, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mecasermin low dose
Arm Type
Active Comparator
Arm Title
mecasermin high dose
Arm Type
Active Comparator
Arm Title
saline placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
mecasermin
Other Intervention Name(s)
rhIGF-1, IGF-1
Intervention Description
Intracoronary bolus
Intervention Type
Drug
Intervention Name(s)
mecasermin
Other Intervention Name(s)
rhIGF-1, IGF-1
Intervention Description
Intracoronary bolus
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride injection
Other Intervention Name(s)
normal saline
Intervention Description
Intracoronary bolus
Primary Outcome Measure Information:
Title
Serum glucose measurement
Description
Safety outcome measure
Time Frame
30 minutes after study drug administration
Title
Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)
Description
Efficacy outcome measure
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Caplice, MB, PhD
Organizational Affiliation
University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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