Status:
COMPLETED
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
Lead Sponsor:
University College Cork
Conditions:
Heart Failure
Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 prote...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01438086
Start Date
October 1 2011
End Date
December 1 2016
Last Update
March 30 2017
Active Locations (2)
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1
Cork University Hospital
Cork, Ireland
2
Leiden University Medical Center
Leiden, Netherlands