COVID-19 Clinical Trials: A Primer for the Cardiovascular and Cardio-Oncology Communities.
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ABSTRACT:
SUBMITTER: Ky B
PROVIDER: S-EPMC7162643 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:SummaryThe coronavirus disease-2019 (COVID-19) pandemic has resulted in a proliferation of clinical trials designed to slow the spread of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Many therapeutic agents that are being used to treat patients with COVID-19 are repurposed treatments for influenza, Ebola, or for malaria that were developed decades ago and are unlikely to be familiar to the cardiovascular and cardio-oncology communities. Here, the authors provide a foundation for cardiovascular and cardio-oncology physicians on the front line providing care to patients with COVID-19, so that they may better understand the emerging cardiovascular epidemiology and the biological rationale for the clinical trials that are ongoing for the treatment of patients with COVID-19.
| S-EPMC7251194 | biostudies-literature
Project description:The coronavirus disease-2019 (COVID-19) pandemic has resulted in a proliferation of clinical trials designed to slow the spread of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Many therapeutic agents that are being used to treat patients with COVID-19 are repurposed treatments for influenza, Ebola, or for malaria that were developed decades ago and are unlikely to be familiar to the cardiovascular and cardio-oncology communities. Here, we provide a foundation for cardiovascular and cardio-oncology physicians on the front line providing care to patients with COVID-19, so that they may better understand the emerging cardiovascular epidemiology and the biological rationale for the clinical trials that are ongoing for the treatment of patients with COVID-19.
| S-EPMC7164888 | biostudies-literature
Project description:Overlapping commonalities between coronavirus disease of 2019 (COVID-19) and cardio-oncology regarding cardiovascular toxicities (CVT), pathophysiology, and pharmacology are special topics emerging during the pandemic. In this perspective, we consider an array of CVT common to both COVID-19 and cardio-oncology, including cardiomyopathy, ischemia, conduction abnormalities, myopericarditis, and right ventricular (RV) failure. We also emphasize the higher risk of severe COVID-19 illness in patients with cardiovascular disease (CVD) or its risk factors or cancer. We explore commonalities in the underlying pathophysiology observed in COVID-19 and cardio-oncology, including inflammation, cytokine release, the renin-angiotensin-aldosterone-system, coagulopathy, microthrombosis, and endothelial dysfunction. In addition, we examine common pharmacologic management strategies that have been elucidated for CVT from COVID-19 and various cancer therapies. The use of corticosteroids, as well as antibodies and inhibitors of various molecules mediating inflammation and cytokine release syndrome, are discussed. The impact of angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) is also addressed, since these drugs are used in cardio-oncology and have received considerable attention during the COVID-19 pandemic, since the culprit virus enters human cells via the angiotensin converting enzyme 2 (ACE2) receptor. There are therefore several areas of overlap, similarity, and interaction in the toxicity, pathophysiology, and pharmacology profiles in COVID-19 and cardio-oncology syndromes. Learning more about either will likely provide some level of insight into both. We discuss each of these topics in this viewpoint, as well as what we foresee as evolving future directions to consider in cardio-oncology during the pandemic and beyond. Finally, we highlight commonalities in health disparities in COVID-19 and cardio-oncology and encourage continued development and implementation of innovative solutions to improve equity in health and healing.
| S-EPMC7746643 | biostudies-literature
Project description:Coronavirus disease 2019 (COVID-19) has emerged as a global pandemic and public health crisis. Increasing waves of intermittent infectious outbreaks have dramatically influenced care among broad populations. Over the past 2 decades, there has been a rapid increase in cancer survival, with >400 000 new survivors each year. The increasingly common presence of cardiovascular disease in patients during or after cancer treatment led to the rapid growth of the field of cardio-oncology with a mandate of identifying, treating, and preventing the various forms of cardiovascular disease seen among this population. This review evaluates the implications of the pandemic on the practice and study of cardio-oncology. The evolving understanding of the relationship between comorbid disease and clinical outcomes among this population is assessed. With the impetus of the pandemic, cardio-oncology can be deliberate in embracing changes to cardiac screening, monitoring, and intervention during oncology care. Bridging 2 specialties, consideration of the lessons learned in cancer and cardiovascular may pivotally inform ongoing therapeutic efforts. Further, the development of multicenter registries focused on understanding and optimizing outcomes among these patients should be considered. Together, these insights may critically inform strategies for the care of cardio-oncology patients in future phases of the COVID-19 pandemic and beyond.
| S-EPMC7792393 | biostudies-literature
Project description:Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility.
| S-EPMC7957448 | biostudies-literature
Project description:Cardio-oncology is a subspecialty of cardiology. It was created to address oncology data indicating that newly developed drugs for cancer treatment were having unanticipated cardiac side effects. Cardio-oncology designs primary and secondary risk strategies through surveillance as well as interventions to reduce cardiovascular risk (CVR), prevent cardiotoxicities, and manage the side effects that may occur. Rather than discuss in detail the cardiotoxicities of specific therapies or radiation, this review article will explore the interplay of cancer, cancer treatment, and CVR. It will examine the link between CVR and cancer risk, define mechanisms associated with cardiotoxicity, and describe screening and surveillance for patients undergoing cancer treatment. Finally, effective preventative and management strategies used to reduce the incidence of cardiotoxicities in those receiving chemotherapeutics or radiation will be presented.
| S-EPMC6303003 | biostudies-literature
Project description:BackgroundWe aim to establish the characteristics of published cardio-oncology research of clinical trials by bibliometric analysis and to talk about the prospects and difficulties facing the development of cardio-oncology.MethodsSearch of data related to clinical trials in cardiac oncology from 1990 to 2022 from the Web of Science core collection. Using CiteSpace to perform co-citation analysis of authors, countries (regions) and institutions, journals and cited journals, cited authors and cited literature, and keywords.ResultsOf the 607 clinical trial studies, the number of papers published per year has increased over time. The regions with the greatest influence were North America (especially the United States) and Europe. Multicenter research has always been the focus of cardio-oncology research, but cross-regional cooperation was still lacking. Myocardial toxicity caused by anthracyclines has received the earliest attention and has been studied for the longest time. Meanwhile, the efficacy and cardiotoxicity of new anticancer drugs always came into focus, but at a slow pace. Few studies on myocardial toxicity were related to the treatment of tumors except breast cancer. Risk factors, heart disease, adverse outcomes, follow-up, and intervention protection were the major hotspots revealed by co-citation cluster.ConclusionsThere is great potential for the development of clinical trials in cardio-oncology, especially in multicenter cooperation across different regions. Expansion of tumor types, myocardial toxicity of different drugs, and effective interventions in the research direction and design of clinical trials are necessary.
| S-EPMC10278509 | biostudies-literature
Project description:BackgroundRe-allocation of resources during the COVID-19 pandemic has resulted in delays in care delivery to patients with cardiovascular disease and cancer. The ability of health care providers to provide optimal care in this setting has not been formally evaluated.ObjectivesTo assess the impact of COVID-19 resource re-allocation on scheduling, testing, elective procedures, telemedicine access, use of new COVID-19 therapies, and providers' opinions on healthcare policies among oncology and cardiology practitioners.MethodsAn electronic survey was conducted by a cardio-oncology collaborative network through regional and state chapters of the American College of Cardiology, American Society of Clinical Oncology, and the International Cardio-Oncology Society. Descriptive statistics were reported by frequency and proportion for analyses, and stratified categorically by geographic region and specialty.ResultsOne thousand four hundred fifteen providers (43 countries) participated: 986 cardiologists, 306 oncologists, and 118 trainees/internal medicine. 63% (195/306) of oncologists vs 92% (896/976) of cardiologists reported cancellations of treatments/elective procedures (p = 0.01). 46% (442/970) of cardiologists and 25% (76/303) of oncologists modified the scope of their practice (p = < 0.001). Academic physicians (74.5%) felt better supplied with personal protective equipment (PPE) vs non-academic (74.5% vs 67.2%; p = 0.018). Telemedicine was less common in Europe 81% (74/91), and Latin America 64% (101/158), than the United States, 88% (950/1097) (p = < 0.001). 95% of all groups supported more active leadership from medical professional societies.ConclusionsThese results support initiatives to promote expanded coverage for telemedicine, increased access to PPE, better testing availability and involvement of medical professional societies to help with preparedness for future health care crisis.
| S-EPMC7691954 | biostudies-literature
Project description:BackgroundClinical outcome assessments (COAs) are key to patient-centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their incorporation in trial outcomes have lagged that of traditional survival and tumor responses. To understand the trends of COA use in oncology and the impact of landmark efforts to promote COA use, we computationally surveyed oncology clinical trials in ClinicalTrials.gov comparing them to the rest of the clinical research landscape.MethodsOncology trials were identified using medical subject heading neoplasm terms. Trials were searched for COA instrument names obtained from PROQOLID. Regression analyses assessed chronological and design-related trends.ResultsEighteen percent of oncology interventional trials initiated 1985-2020 (N = 35,415) reported using one or more of 655 COA instruments. Eighty-four percent of the COA-using trials utilized patient-reported outcomes, with other COA categories used in 4-27% of these trials. Likelihood of COA use increased with progressing trial phase (OR = 1.30, p < 0.001), randomization (OR = 2.32, p < 0.001), use of data monitoring committees (OR = 1.26, p < 0.001), study of non-FDA-regulated interventions (OR = 1.23, p = 0.001), and in supportive care versus treatment-focused trials (OR = 2.94, p < 0.001). Twenty-six percent of non-oncology trials initiated 1985-2020 (N = 244,440) reported COA use; they had similar COA-use predictive factors as oncology trials. COA use increased linearly over time (R = 0.98, p < 0.001), with significant increases following several individual regulatory events.ConclusionWhile COA use across clinical research has increased over time, there remains a need to further promote COA use particularly in early phase and treatment-focused oncology trials.
| S-EPMC10501237 | biostudies-literature
Project description:Cardiotoxicity induced by anti-cancer treatment has become a significant threat as the number of cardiotoxic anti-cancer agents is growing. Cancer patients are at an increased risk of contracting coronavirus disease 2019 (COVID-19) because of immune suppression caused by anti-cancer drugs and/or supportive treatment. Deterioration in lung functions due to COVID-19 is responsible for many cardiac events. The presence of COVID-19 and some of its treatment modalities may increase the chance of cardiotoxicity development in cancer patients receiving potentially cardiotoxic agents. This review provides evidence-based information on the cardiotoxicity risk in cancer patients clinically diagnosed with COVID-19 who are receiving potentially cardiotoxic anti-cancer agents. Proposed strategies relating to the management of this patient cohorts are also discussed.
| S-EPMC7967496 | biostudies-literature