NCT01438086

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 heart-failure

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1 heart-failure

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

4.3 years

First QC Date

September 17, 2011

Last Update Submit

March 28, 2017

Conditions

Heart FailureMyocardial Infarction

Keywords

Heart FailureMyocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

mecasermin low dose

ACTIVE COMPARATOR
Drug: mecasermin

mecasermin high dose

ACTIVE COMPARATOR
Drug: mecasermin

saline placebo

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection

Interventions

mecaserminDRUG

Intracoronary bolus

Also known as: rhIGF-1, IGF-1
mecasermin low dose
0.9% sodium chloride injectionDRUG

Intracoronary bolus

Also known as: normal saline
saline placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cork University Hospital

Cork, Ireland

Location

Leiden University Medical Center

Leiden, Netherlands

Location

MeSH Terms

Conditions

Heart FailureMyocardial Infarction

Interventions

mecaserminInsulin-Like Growth Factor ISodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Noel Caplice, MB, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiovascular Sciences

Study Record Dates

First Submitted

September 17, 2011

First Posted

September 21, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2016

Study Completion

December 1, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

NL(1)IE(1)