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IMPACT-CABG Trial: Implantation of CD133(+) Stem Cells in Patients Undergoing Coronary Bypass Surgery-Presentation of the First Treated Patient.

ABSTRACT: The IMPACT-CABG study is the first Canadian randomized-controlled phase II clinical trial aiming to assess the effect of intramyocardial (IM) injections of CD133(+)-selected stem cells in patients referred for coronary artery bypass graft (CABG) with a "chronic" myocardial infarction and persistent left ventricular dysfunction. Patients are followed for 2 years with different imaging techniques including the stress magnetic resonance to evaluate the global and regional myocardial viability. Before the beginning of the randomization, the 5 first patients are treated in an open-label fashion to assess safety and feasibility of the IM CD133(+) injections. Herein, we report the first Canadian patient treated with IM injection of CD133(+) cells during CABG surgery as part of the IMPACT-CABG trial.

SUBMITTER: Forcillo J

PROVIDER: S-EPMC3505958 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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IMPACT-CABG Trial: Implantation of CD133(+) Stem Cells in Patients Undergoing Coronary Bypass Surgery-Presentation of the First Treated Patient.

Forcillo Jessica J Stevens Louis-Mathieu LM Mansour Samer S Prieto Ignacio I Roy Denis-Claude DC Noiseux Nicolas N

Case reports in transplantation 20110622

The IMPACT-CABG study is the first Canadian randomized-controlled phase II clinical trial aiming to assess the effect of intramyocardial (IM) injections of CD133(+)-selected stem cells in patients referred for coronary artery bypass graft (CABG) with a "chronic" myocardial infarction and persistent left ventricular dysfunction. Patients are followed for 2 years with different imaging techniques including the stress magnetic resonance to evaluate the global and regional myocardial viability. Befo ...[more]

PMID: 23213603

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Project description:BACKGROUNDS:Cardiovascular disease (CVD) is the leading cause of mortality all over the globe. Inflammation is believed to play a pivotal role in the pathophysiology of CVD. While there are studies on the interrelationship of telomerase and vitamin D and their involvement in CVD, their independent contributions to long-term outcomes in patients with CVD are not well-defined. This study aimed to investigate the association of both telomerase and vitamin D concentrations with 10-year survival among candidates of coronary artery bypass grafting (CABG) surgery. METHODS:Participants were 404 patients from Tehran Heart Center-Coronary Outcome Measurement (THC-COM) cohort who were recruited from CABG surgery candidates in 2006. In addition to demographic and clinical data including risk factors for coronary artery disease, laboratory parameters such as markers of inflammation as well as baseline serum 25-hydroxy vitamin D [25(OH)D] and telomerase concentrations were measured. Cardiac function indexes alongside outcome measures such as mortality and survival days were recorded for every patient up to 10 years after CABG. Cox-proportional hazard model was used to study the association between all-cause mortality and research parameters. RESULTS:The mean serum telomerase enzyme level was 24.92 ±21.4 nmol/L and the mean serum 25(OH)D was 27.27±10.3 ng/mL. 10-year mortality was reported in 64 (15.8%) patients. 25(OH)D was categorized into three groups (<20, 20-30, and >30) and the cut-point for telomerase was set at 25.0 nmol/L. In Cox regression analysis, higher levels of telomerase (>25 nmol/L) were significantly associated with longer survival (p = 0.041), whereas 25(OH)D concentrations were not associated with survival time. Further analysis showed that telomerase concentrations significantly predicted survival only in the presence of insufficient levels of 25(OH)D (20-30 ng/mL) (p = 0.037). CONCLUSIONS:Telomerase can be regarded as a potential predictor of long-term outcomes in patients who underwent CABG. However, the association of telomerase with the mortality may be modified by vitamin D concentrations.

Project description:Background: The European System for Cardiac Operative Risk (EuroSCORE) II was developed in 2011 to replace the aging EUROScore for predicting in-house mortality after cardiac surgery. Our aim was to validate EuroSCORE II in Malaysian patients undergoing coronary artery bypass graft (CABG) surgery at our Institute. Methods: A retrospective single-center study was performed. A database was created to include EuroSCORE II values and actual mortality of 1718 patients undergoing CABG surgery in Malaysia from 1st January to 31st December 2016. The goodness-of-fit of EuroSCORE II was determined by the Hosmer-Lemeshow goodness-of-fit test and discriminatory power with the areas under the receiver operating characteristics (ROC) curve (AUC). Results: Observed mortality rate was 4.66% (80 out of 1718 patients). The median EuroSCORE II value was 2.06% (Inter Quartile Range: 1.94%) (1st quartile: 1.45%, 3rd quartile: 3.39%). The AUC for EuroSCORE II was 0.7 (95% CI 0.640 - 0.759) indicating good discriminatory power. The Hosmer-Lemeshow goodness-of-fit test did not show significant difference between expected and observed mortality in accordance to the EuroSCORE II model (Chi-square = 13.758, p = 0.089) suggesting good calibration of the model in this population. Cross-tabulation analysis showed that there is slight overestimation of EuroSCORE II in low-risk groups (0-10%) and slight underestimation in high-risk groups (>20%). Multivariate logistic regression analysis showed that gender, age, total hospital stay, serum creatinine and critical pre-operative state are significant predictors of mortality post-CABG surgery. Conclusion: This study indicated that the EuroSCORE II is a good predictor of post-operative mortality in the context of Malaysian patients undergoing CABG surgery. Our study also showed that certain independent variables might possess higher weightage in predicting mortality among this patient group. Therefore, it is suggested that EuroSCORE II can be safely used for risk assessment while ideally, clinical consideration should be applied on an individual basis.

Dataset Information

IMPACT-CABG Trial: Implantation of CD133(+) Stem Cells in Patients Undergoing Coronary Bypass Surgery-Presentation of the First Treated Patient.

Publications

IMPACT-CABG Trial: Implantation of CD133(+) Stem Cells in Patients Undergoing Coronary Bypass Surgery-Presentation of the First Treated Patient.

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