The Enhanced Angiogenic Cell Therapy in Acute Myocardial Infarction (ENACT-AMI) trial

Phase 2

• Conditions: Acute myocardial infarction; Circulatory System

• Registration Number: ISRCTN47943321
• Lead Sponsor: Ottawa Hospital Research Institute (OHRI) (Canada)

Brief Summary

2010 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/20211295 protocol (added 11/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-17
• Last Update Posted: 12 February 2024
• Study Completion: 2029-09-18

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1. Male or female 18 - 75 years of age
2. Clinical diagnosis of ST-elevation myocardial infarction (MI) of greater than 1 mm in two adjacent electrocardiogram (ECG) limb leads, or greater than 2 mm in two adjacent ECG precordial leads, or a new left bundle branch block and an increase in cardiospecific enzymes (creatine kinase [CK] greater than 3 x upper limit of normal [ULN]), and either positive myocardial bands (MB) fraction or increase in troponin compared to institutional laboratory normal ranges
3. Patients who have suffered an acute Q-wave MI within the preceding 30 days prior to inclusion and have undergone percutaneous coronary intervention (PCI) with stent implantation in the infarct-related artery (IRA)
4. Culprit artery must have distal flow greater than thrombolysis in myocardial infarction (TIMI) 1
5. Left ventricular ejection fraction (LVEF) less than or equal to 45% by echocardiography (Simpson's Method) performed at least 2 days after onset of chest pain
6. In the case of previous MI, must have documentation of LVEF greater than 45% prior to index AMI
7. Females who are surgically sterile, or are post-menopausal, or have documented infertility, or are of child-bearing potential using one of the following methods of contraception:
7.1. Barrier-type devices (e.g., condom, diaphragm) used in combination with a spermicide; a double barrier method is recommended
7.2. Intrauterine devices (IUDs)
7.3. Oral or implanted contraceptives, if used in combination with a barrier method
8. Provided written informed consent

Exclusion Criteria

1. Significant unprotected left main disease (greater than 50% stenosis) on diagnostic angiography
2. Planned coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) for a coronary stenosis greater than 70% in the non-infarct related artery (IRA)
3. History of sustained ventricular arrhythmias not related to AMI (evidenced by previous holter monitoring +/- medication history for sustained ventricular arrhythmias in the subject's medical chart
4. History of cerebrovascular accident or transient ischaemic attack less than or equal to 6 months
5. Any exclusion to magnetic resonance imaging (MRI) (includes already implanted automatic internal defibrillator or permanent pacemaker). Recent stent implantation is NOT an exclusion to MRI.
6. Persistent haemodynamic instability (need for ongoing pharmacological or mechanical support greater than 24 hours of the onset of chest pain)
7. Mechanical ventilatory support
8. Significant cardiac valvular disease
9. Left ventricular (LV) dysfunction from any other cause (e.g., non-ischaemic cardiomyopathy, collagen diseases)
10. Clinical evidence of persistent heart failure not responding to standard oral therapy
11. Clinical evidence of persistent ischaemia at time of cell therapy
12. Current pregnancy or nursing mothers
13. Known history of human immunodeficiency virus (HIV)
14. Known history of hepatitis B or C (hepatitis B surface antigen [HBsAg], hepatitis B [HB] core, hepatitis C [HC] antibody)
15. History of untreated ethanol (ETOH) or drug abuse
16. Creatinine clearance less than 60 by Cockcroft-Gault calculator (SI units)
17. Contraindications to apheresis (inadequate venous access or haematological exclusions)
18. Evidence of active infection
19. Significant co-morbidity (e.g., immunocompromise, hepatic failure)
20. Known history of malignancy in the past 5 years (except for low-grade and fully resolved non-melanoma skin cancer)
21. Known allergy to gentamycin and amphotericin
22. Patients receiving other investigational drug or device therapy within 30 days of screening
23. Patients who have received gene therapy
24. Inability ot provide informed consent and comply with the follow-up visit schedule

Study & Design

• Study Type: Interventional
• Study Design: Not specified