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Introduction: Despite considerable developments made in the representation of women in cardiology (WIC) recently, there still remain substantial disparities in the representation of women participants in clinical trials, as well as women physicians and scientists in clinical trial leadership. Under-representation of women in Randomized Clinical Trials (RCTs) remains the bane of the modern medicine, impeding the development of sexspecific guidelines in cardiovascular diseases. Female leadership in clinical trials has been shown to enhance the inclusion of women as trial participants. Furthermore, while the COVID-19 pandemic has impacted women in academia, there is no data thus far reporting the impact of the pandemic in terms of presenters and leadership of late-breaking clinical trials (LBCT) in cardiology during this period. Purpose(s): We aimed to determine inclusion of WIC in LBCTs leadership and their correlation to inclusion of women in reported RCTs. Method(s): In our comprehensive analysis, we included all LBCTs presented at major international cardiovascular meetings reported over the period of January 2020 to February 2022. Data were derived from the original presentation at the meeting and/or simultaneous/ subsequent publication of manuscript. Sex of the presenter (woman or man), was assessed by either original videos of the presentation at the meeting, or based on pronoun use in the biographies derived from institutional profiles. The presence or absence of reporting of sex distribution of study participants were also recorded from original presentation at the meeting and/or published manuscript. Proportion of women included in each trial was sourced from either original publication or calculated from any similar data shown during the presentations. Result(s): A total of 400 of RCTs from 19 meetings were included with a total of 400 presenters/principal investigators recorded - 32 (8%) women and 368 (92%) men. There were no significant differences between 2020 and 2021 [15 (7.2%) women in 2021 vs. 17 (19.3%) in 2020 (P=0.446)]. Proportions of women included in RCTs with WIC (37.3%) vs. non-WIC (38.7%) presenters were comparable (p=0.559), while 45% of RCTs didn't report sex distribution of participants. Except for 2 meetings (CRT 2020 and 2022), all others were virtual. Conclusion(s): WIC representation as RCTs presenters was significantly low, despite the opportunity of virtual attendance afforded during the COVID-19 pandemic. Modest inclusion of women irrespective of sex of RCT leadership emphasizes multi-level problems that require more actionable solutions: I.e. implicit bias training started as early as medical school, continuing education on necessity for diversity, equity and inclusion, patient and public involvement, and comprehensive guidance on trial design, such that future RCT participants reflect the populations intended to treat. (Figure Presented).
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Introduction: SARS-CoV-2 tropism for the ACE2 receptor, along with the multifaceted inflammatory reaction, is likely to drive the generalized hypercoagulable state seen in patients with COVID-19. Methodology: Using the original bioinformatic workflow and network medicine approaches we reanalyzed four coronavirus-related expression datasets and performed co-expression analysis focused on thrombosis and ACE2 related genes. We identified microRNAs (miRNAs) which play role in ACE2-related thrombosis in coronavirus infection and further, we validated the expressions of those miRNAs in 79 hospitalized COVID-19 patients and 32 healthy volunteers by PCR and monitored miRNAs patterns during the acute phase of COVID-19, as well as the prognostic potential of these miRNAs as biomarkers. Result(s): We identified EGFR, HSP90AA1, APP, TP53, PTEN, UBC, FN1, ELAVL1 and CALM1 as regulatory genes which could play a pivotal role in COVID-19 related thrombosis. We also found miR-16-5p, miR-27a-3p, Let- 7b-5p and miR-155-5p as regulators in coagulation and thrombosis process. We observed in separate cohort of COVID-19 patients and healthy controls that (i) expression of miR-16-5p, miR-27a-3p and miR-155-5p increased during observation, compared to the baseline measurement;(ii) a low baseline miR-16-5p expression presents predictive utility in assessment of the hospital length of stay or death in follow-up as a composite endpoint (AUC: 0.810, 95% CI, 0.71-0.91, p<0.0001);(iii) low baseline expression of miR-16-5p and diabetes mellitus are independent predictors of increased length of stay or death according to a multivariate analysis (OR: 9.417;95% CI, 2.647-33.506;p=0.0005 and OR: 6.257;95% CI, 1.049- 37.316;p=0.044, respectively). Conclusion(s): This study enabled us to better characterize changes in gene expression and signaling pathways related to COVID-19 thrombosis. In this study we identified, characterized and validated miRNAs which could serve as novel, thrombosis-related biomarkers of the COVID-19, can be used for early stratification of patients and prediction of severity of infection development in an individual. (Figure Presented) .
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Background: Various miRNAs, as well as their target genes are involved in the complex pathophysiology of inflammation, immune response, coagulation and CVDs. Thus, they may be useful for diagnosis, prognosis and as a potential therapeutic strategy in multiple pathologies. Aim(s): According to our previously published bioinformatics analysis, we aimed to analyze the diagnostic and predictive utility of miRNAs regulating ACE2 network (miR-26b-5p, miR-10b-5p, miR-302c-5p, hsa-miR-200b-3p, hsa-miR-124-3p) in patients with COVID-19. Result(s): The expression levels of miR-26b-5p in COVID-19 patients were found lower at the baseline, 7 and 21-days after admission. compared to the healthy controls (p<0.0001 for all time points). Similarly, miR-10b-5p expression levels were lower at the baseline and 21-days post admission in COVID-19 patients when compared to the healthy individuals (p=0.001 in both time points). Moreover, expression levels of this miRNA were higher 7- days post-admission when compared to the baseline (p=0.003). According to the ROC curve analysis, low miR-200b-3p expression presents predictive utility in assessment of the hospital length of stay and/or death (AUC: 0.730, p=0.002). According to the multivariable logistic regression model, low delta miR-200p expression, together with diabetes mellitus (DM), are independent predictors of increased hospital length of stay and/or death (OR: 5.775;95% CI, 1.572-21.214;p=0.008 and OR: 4.888;95% CI, 1.001-23.858;p=0.050, respectively). Conclusion(s): This study enabled us to better characterize changes in gene expression and signaling pathways related to COVID-19 thrombosis. In this study we identified, characterized and validated miRNAs which could serve as novel, thrombosis-related biomarkers of the COVID-19, can be used for early stratification of patients and prediction of severity of infection development in an individual. (Figure Presented) .
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Background: SARS-CoV- 2 tropism for the ACE2 receptor, along with the multifaceted inflammatory reaction, is likely to drive the generalized hypercoagulable state seen in patients with COVID-19. Aim(s): According to our previously published bioinformatics analysis, we aimed to analyze the diagnostic and predictive utility of miRNAs regulating ACE2 network (miR-26b- 5p, miR-10b- 5p, miR-302c- 5p, hsa-miR- 200b- 3p, hsa-miR- 124- 3p) in patients with COVID-19 Methods: We determined the expressions of ACE2-related- miRNAs in 79 hospitalized COVID-19 patients and 32 healthy volunteers by PCR and monitored miRNAs patterns during the acute phase of COVID-19, as well as the prognostic potential of these miRNAs as biomarkers. Result(s): The expression levels of miR-26b- 5p in COVID-19 patients were found lower at the baseline, 7 and 21-days after admission. compared to the healthy controls (p < 0.0001 for all time points). Similarly, miR-10b- 5p expression levels were lower at the baseline and 21-days post admission in COVID-19 patients when compared to the healthy individuals (p = 0.001 in both time points). Moreover, expression levels of this miRNA were higher 7-days post-admission when compared to the baseline (p = 0.003). According to the ROC curve analysis, low miR-200b- 3p expression presents predictive utility in assessment of the hospital length of stay and/or death (AUC:0.730, p = 0.002). According to the multivariable logistic regression model, low delta miR-200p expression, together with diabetes mellitus (DM), are independent predictors of increased hospital length of stay and/or death (OR: 5.775;95% CI, 1.572-21.214;p = 0.008 and OR: 4.888;95% CI, 1.001-23.858;p = 0.050, respectively). Conclusion(s): This study enabled us to better characterize changes in gene expression and signaling pathways related to COVID-19 thrombosis. In this study we identified, characterized and validated miRNAs which could serve as novel, thrombosis-related biomarkers of the COVID-19, can be used for early stratification of patients and prediction of severity of infection development in an individual. (Figure Presented).
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Background: SARS-CoV- 2 tropism for the ACE2 receptor, along with the multifaceted inflammatory reaction, is likely to drive the generalized hypercoagulable state seen in patients with COVID-19. Aim(s): We aimed identify microRNAs (miRNAs) play role in ACE2-related thrombosis in coronavirus infection and validated the expressions of those miRNAs in 79 hospitalized COVID-19 patients and 32 healthy volunteers and monitored miRNAs patterns during the acute phase of COVID-19, as well as the prognostic potential biomarker. Method(s): Using the original bioinformatic workflow and network medicine approaches we reanalyzed four coronavirus-related expression datasets and performed co-expression analysis focused on thrombosis and ACE2 related genes. Blood RNA;quality RNA was assessed: Fluorometric assay;RT-PCR for miRNAs expression measurement. Result(s): We identified EGFR, HSP90AA1, APP, TP53, PTEN, UBC, FN1, ELAVL1 and CALM1 as regulatory genes which could play a pivotal role in COVID-19 related thrombosis. We also found miR-16- 5p, miR-27a- 3p, Let-7b- 5p and miR-155- 5p as regulators in coagulation and thrombosis process. We observed in separate cohort of COVID-19 patients and healthy controls that (i) expression of miR-16- 5p, miR-27a- 3p and miR-155- 5p increased during observation, compared to the baseline measurement;(ii) a low baseline miR-16- 5p expression presents predictive utility in assessment of the hospital length of stay or death in follow-up as a composite endpoint (AUC:0.810, 95% CI, 0.71-0.91, p < 0.0001);(iii) low baseline expression of miR-16- 5p and T2DM are independent predictors of increased length of stay or death according to a multivariate analysis (OR: 9.417;95% CI, 2.647-33.506;p = 0.0005 and OR: 6.257;95% CI, 1.049-37.316;p = 0.044). Conclusion(s): This study enabled us to better characterize changes in gene expression and signaling pathways related to COVID-19 thrombosis. In this study we identified, characterized and validated miRNAs which could serve as novel, thrombosis-related biomarkers of the COVID-19, can be used for early stratification of patients and prediction of severity of infection development in an individual. (Figure Presented).