Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack (RESUS-AMI)

Phase 3

Withdrawn

• Conditions: acute myocardial infarction with LVEF< 30%; heart attack with heartfailure; 10011082

• Registration Number: NL-OMON40846
• Lead Sponsor: niversity college Cork, Centre for Research in Vascular Biology  Bio Sciences Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

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 (ECG) 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 PCI for STEMI
5. LVEF during PCI < 40%
6. TIMI flow grade 3 in IRA following reperfusion and stenting

Exclusion Criteria

4.3 EXCLUSION CRITERIA
Subjects having any of the following criteria will not be enrolled in the study:
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 (SBP<80mm Hg requiring pressors or IABP)
6. Estimated glomerular filtration rate (eGFR) < 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 (e.g. pacemaker, implanted cardiac defibrillator or other magnetically activated device, aneurysm clips, claustrophobia)
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: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint to be measured during this study is the percent<br /><br>change from baseline in LVEF at 8 weeks measured by quantitative cardiac MRI</p><br>