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Health Condition(s) or Problem
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Acute Myocardial Infarction
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Lay Summary
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An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial
with central core lab analyses to determine the safety of intra-coronary infusion of
enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days
after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation
myocardial infarction (STEMI).
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.
- ST-segment elevation >=2mm in >=3 adjacent leads.
- Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on
echocardiogram at 48-72 hrs after primary PCI.
- Age between 20 and 75 years.
Exclusion Criteria:
- Pregnant or lactating.
- Prior history of myocardial infarction before index event.
- Decompensated congestive heart failure.
- Pre-existent LV dysfunction (EF <45% prior to admission)
- Cardiomyopathy.
- Previous cardiac surgery.
- Congenital heart disorder.
- Serum creatinine >200 Mmol/L.
- Presence of permanent pacemaker or implantable defibrillator.
- Contraindication to bone marrow aspiration.
- History of malignancy within 5 years except curatively treated basal cell carcinoma,
squamous cell carcinoma and/or cervical carcinoma.
- Sustained or inducible VT >48 hours post primary PCI.
- Three vessel coronary artery disease necessitating intervention within 4 months.
- Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B
virus (HBV) and hepatitis C virus (HCV) infection.
- Presence of chronic systemic inflammatory disorders.
- Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or
prior solid organ transplantation.
- Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.
- Any condition associated with a life expectancy of less than 6 months.
- Participation in unrelated research involving investigational pharmacological
agent(s) 30 days before planned dosing.
- Current alcohol or drug abuse.
- Inability to provide written informed consent.
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Who cannot enter the trial
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Inclusion Criteria:
- Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.
- ST-segment elevation >=2mm in >=3 adjacent leads.
- Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on
echocardiogram at 48-72 hrs after primary PCI.
- Age between 20 and 75 years.
Exclusion Criteria:
- Pregnant or lactating.
- Prior history of myocardial infarction before index event.
- Decompensated congestive heart failure.
- Pre-existent LV dysfunction (EF <45% prior to admission)
- Cardiomyopathy.
- Previous cardiac surgery.
- Congenital heart disorder.
- Serum creatinine >200 Mmol/L.
- Presence of permanent pacemaker or implantable defibrillator.
- Contraindication to bone marrow aspiration.
- History of malignancy within 5 years except curatively treated basal cell carcinoma,
squamous cell carcinoma and/or cervical carcinoma.
- Sustained or inducible VT >48 hours post primary PCI.
- Three vessel coronary artery disease necessitating intervention within 4 months.
- Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B
virus (HBV) and hepatitis C virus (HCV) infection.
- Presence of chronic systemic inflammatory disorders.
- Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or
prior solid organ transplantation.
- Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.
- Any condition associated with a life expectancy of less than 6 months.
- Participation in unrelated research involving investigational pharmacological
agent(s) 30 days before planned dosing.
- Current alcohol or drug abuse.
- Inability to provide written informed consent.
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What will happen
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Other; CD133+ infusion; Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).; 1; Other; placebo infusion; Buffered normal saline will be infused in the coronary artery during an angiography.; 2
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Primary aim
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PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.; PRIMARY EFFICACY ENDPOINT Comparison of changes in myocardial thickening in non-viable akinetic / hypokinetic LV wall segments as determined by cardiac magnetic resonance imaging (cMRI) in treated and control groups.
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Secondary Aim
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SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.; At all follow up's; Yes; SECONDARY EFFICACY ENDPOINTS (a) Changes in % global LV ejection fraction (EF) compared with baseline as determined by cMRI and echocardiography pre- and post-cell infusion subsequent to primary PCI.; at all follow up's; No; SECONDARY EFFICACY ENDPOINTS (b)Assessment of epicardial resistance and microvascular resistance, index of myocardial resistance and absolute coronary blood flow measurements in the infarct related artery.; at 6 months follow up; No; SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.; prior to the infusion; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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