Status:
ACTIVE_NOT_RECRUITING
The Enhanced Angiogenic Cell Therapy - Acute Myocardial Infarction Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Stem Cell Network
Conditions:
Anterior Wall Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This will be the first clinical trial to include a strategy designed to enhance the function of autologous progenitor cells by overexpressing eNOS, and the first to use combination gene and cell thera...
Detailed Description
Introduction: * Despite the widespread use of pharmacological and/or interventional reperfusion therapies, recovery of cardiac function in myocardial infarction patients is often modest or in some ca...
Eligibility Criteria
Inclusion
- Male or female 18-80 years of age
- Clinical diagnosis of anterior ST-elevation myocardial infarction within the last 30 days, with any one of the following 12-lead electrocardiographic changes:
- a) Greater than or equal to 1 mm ST elevation or new Q waves in 2 adjacent electrocardiographic precordial leads
- b) A new left bundle branch block AND and for patients presenting within 3 days of onset of chest pain an increase in cardiospecific enzymes (\>3x CK with, EITHER positive MB fraction or increase in troponin compared to institution laboratory normal ranges)
- Successful PCI with stent implantation to infarct-related artery within the last 30 days; defined as residual stenosis no greater than 30%, TIMI flow of at least 2 or greater and a reference diameter of at least \> 2mm
- Is considered hemodynamically stable at time of enrollment and immediately prior to cell delivery
- Screening LVEF must be no greater than 45% by echocardiography (determined by Simpson's method) performed at least 4 days after revascularization procedure. (All screening echos done within the first 4 days post-PCI must be repeated either by echocardiography or MRI prior to cell delivery to ensure that the variability does not exceed 10%)
- In the case of a previous myocardial infarction, documented LVEF must be 55% or greater
- Female participants MUST be surgically sterile, post-menopausal, have documented infertility, or are of child-bearing potential wih laboratory confirmation of non-pregnant state
- Provided written informed consent and is willing to comply with study follow-up visits
Exclusion
- Significant unprotected left main disease (stenosis of 50% or greater on diagnostic angiography)
- An increase in LVEF by greater that 10% from initial LVEF evaluation for repeat assessments
- The presence of significant coronary lesions, other than the index lesion of the IRA
- A history of significant ventricular arrhythmia NOT related to index STEMI
- A history of cerebro-vascular accident or transient ischemic attack within 6 months of enrollment
- Meets at least one exclusion criterion for MRI (NB: Recent stent implantation is not an exclusion)
- Inability to undergo apheresis procedure (i.e.: poor venous access, laboratory abnormalities)
- A history of uncorrected significant valvular heart disease
- A history of left ventricular dysfunction prior to index STEMI
- A history of human immunodeficiency virus (HIV) or hepatitis B or C infection
- A history of malignancy within 5 years (Except for low-grade and fully resolved non-melanoma skin cancer)
- A history of allergy to gentamycin or amphotericin
- A history of Heparin-Induced Thrombocytopenia (HIT)
- A history of non-compliance
- Active inflammatory autoimmune disease requiring chronic immunosuppressive therapy
- Creatinine clearance \<60 by Cockcroft-Gault Calculator
- Confirmed pregnant or lactating
- Is enrolled in a current investigational drug or device trial
- Participant has received cell or gene therapy in past
- The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial
- Inability to provide informed consent and comply with the follow-up visit schedule
Key Trial Info
Start Date :
July 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2029
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00936819
Start Date
July 19 2013
End Date
November 1 2029
Last Update
August 15 2025
Active Locations (3)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
3
L'institut de cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8