COMPARE-AMI trial: Comparison of intracoronary injection of CD133 + bone marrow stem cells to placebo in patients after acute myocardial infarction and left ventricular dysfunction: Study rationale and design
Mansour S.,Center Hospitalier Of Luniversite Of Montreal Chum |
Roy D.-C.,Hopital Maisonneuve Rosemont HMR |
Bouchard V.,University of Montreal |
Nguyen B.K.,Center Hospitalier Of Luniversite Of Montreal Chum |
And 6 more authors.
Journal of Cardiovascular Translational Research | Year: 2010
Stem cell therapy has emerged as a promising approach to improve healing of the infarcted myocardium, to treat or prevent cardiac failure, and to restore lost cardiac function. Despite initial excitement, recent clinical trials using nonhomogenous human stem cells preparations showed variable results, raising concerns about the best cell type to transplant. Selected CD133+ hematopoietic stem cells are promising candidate cells with great potential. COMPARE-acute myocardial infarction (AMI) study is a phase II, randomized, double-blind, placebocontrolled trial evaluating the safety and effectiveness of intracoronary CD133+ -enriched hematopoietic bone marrow stem cells in patients with acute myocardial infarction and persistent left ventricular dysfunction. Patients who underwent successful percutaneous coronary intervention and present a persistent left ventricular ejection fraction ≤ 50% will be eligible to have bone marrow aspiration and randomized for intracoronary injection of selected CD 133+ bone marrow cells vs placebo. The primary end point is a composite of a safety and efficacy end points evaluating the change at 4 months in the coronary atherosclerotic burden progression proximal and distal to the coronary stent in the infarct related artery; and the change in global left ventricular ejection fraction at 4 months relative to baseline as measured by magnetic resonance imaging. The secondary end point will be the occurrence of a major adverse cardiac event. To date, 14 patients were successfully randomized and treated without any protocol-related complication. COMPARE-AMI trial will help identify the effect of a selected population of the bone marrow stem cells on cardiac recovery of infarcted myocardium. © Springer Science + Business Media, LLC 2009.
Zimmermann M.,Center Hospitalier Of Luniversite Of Montreal Chum Hopital Notre Dame |
Taussky D.,Center Hospitalier Of Luniversite Of Montreal Chum Hopital Notre Dame |
Menkarios C.,Hopital Maisonneuve Rosemont HMR |
Vigneault E.,University of Quebec |
And 5 more authors.
Clinical Oncology | Year: 2016
Aims: To report the long-term toxicities and sexual quality of life of a once-weekly hypofractionated radiation therapy schedule for low-risk prostate cancer. Materials and methods: A multi-institutional phase II trial was conducted, using a three-dimensional conformal radiation therapy (3D-CRT) approach for low-risk prostate cancer (T1a-T2a, Gleason ≤ 6 and prostate-specific antigen ≤ 10 ng/ml). Forty-five Gray (Gy) were delivered in nine fractions of 5 Gy given on a weekly basis. Acute and late genitourinary and gastrointestinal toxicities were graded according to the Radiation Therapy Oncology Group toxicity scale. Sexual function and sexual bother were assessed with the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. Results: Between March 2006 and August 2008, 80 patients were treated, with a median age of 69 years (interquartile range 64-72). The median follow-up was 83 months (interquartile range 73-85 months). At 7 years, overall survival was 88%. No patients died of prostate cancer. Cumulative grade ≥2 genitourinary and gastrointestinal late toxicity was reported for 31.3% and 30% of our patients, respectively. Cumulative grade ≥3 genitourinary and gastrointestinal late toxicity was seen in 3.8% and 12.5% of cases, respectively. Late genitourinary grade 2 toxicity was correlated with the occurrence of acute genitourinary grade 2 toxicity (P = 0.006). The occurrence of late gastrointestinal toxicity was not correlated with acute gastrointestinal toxicity. Pre-treatment EPIC sexual function was low (37.5%) and the mean EPIC sexual function score at 7 years after treatment was 14%. On the other hand, pre-treatment EPIC sexual bother reached 80.5%, meaning little bother, and remained stable during follow-up. Conclusions: Once-weekly 3D-CRT leads to excellent biochemical disease-free survival and acceptable toxicities. Pre-treatment EPIC sexual function dropped by 42% at 5 years of follow-up. This functional deficit did not bother patients, possibly due to the already low sexual function at baseline. © 2015 The Royal College of Radiologists.
Picard M.,Hopital Maisonneuve Rosemont HMR |
Picard M.,Center Hospitalier Of Luniversite Of Montreal Chum |
Begin P.,Hopital Maisonneuve Rosemont HMR |
Begin P.,Center Hospitalier Of Luniversite Of Montreal Chum |
And 7 more authors.
Journal of Allergy and Clinical Immunology: In Practice | Year: 2013
Background: Prescribing antibiotics to patients with a history of penicillin allergy is common in clinical practice. Opting for non-beta-lactam antibiotics has its inconveniences and is often unnecessary, because most of these patients are in fact not allergic. Objective: This study aimed to determine how physicians in a large Canadian tertiary-care academic hospital without allergists on staff treat patients with a history of penicillin allergy. Methods: A retrospective study was conducted during a 1-year period among all patients hospitalized in the intensive care unit, coronary care unit, and internal medicine wards. Files of patients with a record of penicillin allergy were reviewed to assess the need for antibiotics during their hospitalization and the decision-making process underlying the choice of antibiotic. The additional costs of alternative antibiotics were calculated. Results: The files of 1738 patients admitted over a 1-year period were hand reviewed. A history of penicillin allergy was found in 172 patients (9.9%). The allergic reaction was described in only 30% of cases and left unmentioned in 20.7%. Beta-lactam antibiotics were used on 56 occasions despite a history of penicillin allergy. The use of alternative antibiotics in place of the beta-lactam standard of care carried an additional cost of $15,672 Canadian. Conclusion: Alleged penicillin allergy is common among hospitalized patients and leads to substantial additional costs. Poor documentation of penicillin allergy likely reflects a lack of knowledge on this issue in the medical community, which impairs optimal treatment of these patients. Increased education on this matter is needed, and allergists on staff could be part of the solution. © 2013 American Academy of Allergy, Asthma & Immunology.
Forcillo J.,Center Hospitalier Of Luniversite Of Montreal |
Stevens L.-M.,Center Hospitalier Of Luniversite Of Montreal |
Stevens L.-M.,Center Hospitalier Of Luniversite Of Montreal Chum Research Center Crchum |
Mansour S.,Center Hospitalier Of Luniversite Of Montreal Chum Research Center Crchum |
And 8 more authors.
Canadian Journal of Cardiology | Year: 2013
Background: The Implantation of Autologous CD133+ Stem Cells in Patients Undergoing CABG (IMPACT-CABG) trial is investigating the feasibility, safety, and efficacy of intramyocardial injections of autologous CD133+ stem cells during coronary artery bypass grafting (CABG) in patients with chronic ischemic cardiomyopathy. We are reporting the results of the first 5 open-label patients. Methods: Bone marrow was harvested from iliac crests and stem cells were isolated using the CliniMACS CD133+ Reagent System (Miltenyi Biotec, GmbH, Bergisch Gladbach, Germany). Patients received CABG, followed by CD133+ cellular injection in the revascularized hypokinetic myocardium. Results: Five males New York Heart Association (NYHA) class III patients aged 64 ± 10 years were treated. Immunomagnetic cell processing allowed an average of 100 ± 48-fold enrichment in CD133+ cells, with 92 ± 11% recovery after selection. Mean number of CD133+ cells injected was 8.4 ± 1.2 million. There were no protocol-related complications during the 18-month follow-up and all patients improved to NYHA class I. Six-month echocardiography showed no significant improvement in left ventricular ejection fraction (34 ± 2% at baseline vs 38 ± 12%: P = 0.50). However, cardiac magnetic resonance showed that systolic wall thickening increased from 15.0 ± 10.5% to 29.0 ± 22.1% (P = 0.01). In addition, mean segmental wall thickness also improved in comparison with baseline (10.7 ± 2.7% to 12.1 ± 4.8%; P < 0.01). Conclusions: This work represents the first Canadian experience with CD133+ stem cells for the treatment of chronic ischemic cardiomyopathy. These results demonstrate the initial safety and feasibility of the IMPACT-CABG pilot trial. Subsequent patients are now being randomized to receive either CD133+ stem cell or placebo. © 2013 Canadian Cardiovascular Society.