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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000480-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mecasermin low dose | Active Comparator |
| |
| mecasermin high dose | Active Comparator |
| |
| saline placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mecasermin | Drug | Intracoronary bolus |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum glucose measurement | Safety outcome measure | 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 | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Caplice, MB, PhD | University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Hospital | Cork | Ireland | ||||
| Leiden University Medical Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 19, 2017 | |
| Reset | Jun 29, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 19, 2017 | Jun 29, 2018 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000604197 | mecasermin |
| D007334 | Insulin-Like Growth Factor I |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013002 | Somatomedins |
| D000096764 | Insulin-Like Peptides |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| mecasermin | Drug | Intracoronary bolus |
|
|
| 0.9% sodium chloride injection | Drug | Intracoronary bolus |
|
|
| Leiden |
| Netherlands |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |