- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01438086
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack (RESUS-AMI)
March 28, 2017 updated by: Professor Noel Caplice, University College Cork
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cork, Ireland
- Cork University Hospital
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Leiden, Netherlands
- Leiden University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: mecasermin low dose
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Intracoronary bolus
Other Names:
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Active Comparator: mecasermin high dose
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Intracoronary bolus
Other Names:
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Placebo Comparator: saline placebo
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Intracoronary bolus
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum glucose measurement
Time Frame: 30 minutes after study drug administration
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Safety outcome measure
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30 minutes after study drug administration
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Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)
Time Frame: Baseline and 8 weeks
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Efficacy outcome measure
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Baseline and 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Noel Caplice, MB, PhD, University College Cork
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2011
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 17, 2011
First Submitted That Met QC Criteria
September 20, 2011
First Posted (Estimate)
September 21, 2011
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCC-IGF-001
- 2011-000480-27 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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