Heart FailurePhase 1/2RESUS-AMINCT01438086
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
A Phase 1/2 study testing mecasermin and 0.9% sodium chloride injection in people with Heart Failure and Myocardial Infarction, run by University College Cork at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Myocardial Infarction
- What is being tested?
- mecasermin and 0.9% sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2011to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
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.
- Conditions
- Heart Failure, Myocardial Infarction
- Being tested
- mecasermin, 0.9% sodium chloride injection
- Keywords
- Heart Failure, Myocardial Infarction
- Medical subject headings
- Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mecaserminDrug
Also called rhIGF-1, IGF-1
Intracoronary bolus
mecaserminDrug
Also called rhIGF-1, IGF-1
Intracoronary bolus
0.9% sodium chloride injectionDrug
Also called normal saline
Intracoronary bolus
| Study group | Role | What they receive |
|---|---|---|
| mecasermin low dose | Active comparator | Not described Receives: Drug: mecasermin |
| mecasermin high dose | Active comparator | Not described Receives: Drug: mecasermin |
| saline placebo | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose measurement
Safety outcome measure
Measured: 30 minutes after study drug administration
Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)
Efficacy outcome measure
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Noel Caplice, University College Cork
- Investigators
- Noel Caplice, MB, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438086
- Sponsor's protocol ID
- UCC-IGF-001
- Other IDs
- 2011-000480-27
- Acronym
- RESUS-AMI
- Status last verified
- Mar 2017
- First submitted
- 17 Sep 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01438086
- Acronym / sponsor ID
- RESUS-AMI / UCC-IGF-001
- Conditions
- Heart Failure, Myocardial Infarction
- Keywords
- Heart Failure, Myocardial Infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mecasermin low dose | Active comparator | Drug: mecasermin |
| mecasermin high dose | Active comparator | Drug: mecasermin |
| saline placebo | Placebo comparator | Drug: 0.9% sodium chloride injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mecaserminAlso: rhIGF-1, IGF-1Intracoronary bolus | Drug | mecasermin low dose |
| mecaserminAlso: rhIGF-1, IGF-1Intracoronary bolus | Drug | mecasermin high dose |
| 0.9% sodium chloride injectionAlso: normal salineIntracoronary bolus | Drug | saline placebo |
Primary outcome
Serum glucose measurement
Time frame: 30 minutes after study drug administration
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
Efficacy outcome measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel Caplice, MB, PhD principal investigator
University College Cork
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mecasermin and 0.9% sodium chloride injection in people with Heart Failure and Myocardial Infarction, run by University College Cork at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum glucose measurement (time frame: 30 minutes after study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.