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Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
Plain-language guide to NCT01438086: phase 1, phase 2 randomized trial of IGF-1 LR3 and Mecasermin (rhIGF-1), 47 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01438086
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2011-10
- Completion (planned or actual)
- 2016-02
- Participants
- 47 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Heart Failure; Myocardial Infarction
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1, phase 2 trial tested IGF-1 LR3 and Mecasermin (rhIGF-1).
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.
It had three arms (groups): one (active comparator), one (active comparator) and saline placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 47 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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. TIMI flow grade 3 in the infarct-related artery following reperfusion and stenting.
The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: history of prior myocardial infarction; prior history of heart failure, left ventricular dysfunction or cardiomyopathy; active or suspected neoplasia.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the IGF-1 LR3 group and the comparison group should start out alike.
The IGF-1 LR3 group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received IGF-1 LR3.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2011-10 with completion listed for 2016-02.
It ran at 2 sites in Ireland (1) and Netherlands (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Serum glucose measurement (time frame: 30 minutes after study drug administration). Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI) (time frame: Baseline and 8 weeks).
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of IGF-1 LR3 and Mecasermin (rhIGF-1) in 47 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the IGF-1 LR3 compound page and the Mecasermin (rhIGF-1) compound page, all human trials.
Our Notes on the Compounds
IGF-1 LR3: A modified IGF-1 analog that escapes binding proteins, so it stays active ≥24 h.
Mecasermin (rhIGF-1): FDA-approved recombinant human IGF-1 for severe primary IGF-1 deficiency in children; distinct from IGF-1 LR3 and IGF-1 DES.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.