Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients with a Heart Attack

Phase 1

• Conditions: ST Elevation Myocardial Infarction; MedDRA version: 17.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000480-27-IE
• Lead Sponsor: niversity College Cork

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-06
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Age 18 – 75
2. Subject presents to hospital within 2-12 hours of the onset of myocardial ischemic pain of at least 30 minutes duration
3. Twelve-lead electrocardiogram reveals one of the following: ST-segment elevation * 0.1 mV in two or more limb leads, or * 0.2 mV in two or more contiguous precordial leads indicative of acute myocardial infarction, or left bundle-branch block
4. Undergoing percutaneous coronary intervention (PCI) for ST elevation myocardial infarction
5. Left ventricular ejection fraction during PCI < or = 40%
6. TIMI flow grade 3 in infarct related artery following reperfusion and stenting
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

1. History of prior myocardial infarction
2. Prior history of heart failure, left ventricular dysfunction or cardiomyopathy
3. Active or suspected neoplasia
4. Known impaired liver function
5. Cardiogenic shock
6. Estimated glomerular filtration rate < 45 ml/min/1.73m2
7. History of hypoglycaemia requiring hospitalisation
8. History of primary insulin growth factor-1 deficiency or growth hormone disorders including acromegaly
9. Contraindication to cardiac MRI
10. Pregnancy (for women of childbearing potential, have a negative pregnancy test at screening) or nursing mothers
11. Known allergy to study drug or any of its inactive ingredients
12. Treatment with another investigational agent within 30 days of enrolment
13. Subjects unable or unwilling to comply with follow-up requirements of study
14. Subjects unable to provide written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified