key: cord-0993284-w02hjyk1 authors: Santi, Ricardo Lopez; Piskorz, Daniel Leonardo; Marquez, Manlio F.; Ramos, Cristhian Ramirez; Renna, Nicolás Federico; Ibarrola, Martin; Wyss, Fernando Stuardo; Dominguez, Adrián Naranjo; Perez, Gonzalo Emanuel; Farina, Juan María; Forte, Ezequiel; Juarez Lloclla, Jorge Paul; Flores de Espinal, Emma; Barragan, Adriana Puente; Ruise, Mauro Gabriel; Delgado, Diego; Baranchuk, Adrian title: Impact of the pandemic on non-infected cardiometabolic patients. A survey in countries of Latin America Rationale and design of CorCOVID LATAM Study date: 2020-08-28 journal: CJC Open DOI: 10.1016/j.cjco.2020.08.007 sha: 9c5e4c5dd42f38f911a9d9441e37ecde87b7fee3 doc_id: 993284 cord_uid: w02hjyk1 BACKGROUND: The first case of COVID-19 was detected in Latin America on February 26(th), 2020, in Brazil. Later in June, the World Health Organization announced that the focus of the outbreak had shifted to Latin America, where countries already had poor control indicators of Non-Communicable Diseases (NCD). Concerns about coronavirus infection led to a reduced number of visits and hospitalizations in patients with NCD, such as cardiovascular diseases, diabetes, and cancer. There is a need to determine the impact of COVID-19 pandemic on patients with cardiometabolic diseases who do not have clinical evidence of COVID-19 infection. METHODS: The CorCOVID LATAM is a cross sectional survey including ambulatory cardiometabolic patients without history or evidence of COVID-19 infection. The study will be conducted by Interamerican Society of Cardiology. An online survey composed by 38 questions using Google Forms will be distributed to patients of 13 Latin American Spanish-speaking countries from June 15th to July 15th, 2020. Data will be analyzed by country and regions. Seven clusters of questions will be analyzed: demographics, socioeconomic and educational level, cardiometabolic profile, lifestyle and habits, body weight perception, medical follow-up and treatments, and psychological symptoms. RESULTS: Final results will be available upon completion of the study. CONCLUSION: The present study will provide answers regarding the impact of COVID-19 pandemic on non-infected cardiometabolic patients. There is scarce data on this topic since it is an unprecedented hostile scenario without short-term solutions. The evolution of knowledge about the SARS-CoV-2 and cardiac involvement, such as the entry pathway by Angiotensin-converting enzyme 2 (ACE2), prognostic cardiovascular (CV) risk factors, and early diagnosis of myocardial injury in critically ill patients, have built a strong connection between this new disease and cardiometabolic patients. [1] [2] [3] Since the first case of COVID 19 was identified in Wuhan, China on December 31 st , 2019, almost all the countries of the world have adopted prevention measures like hand hygiene and social distancing, use of masks and partial or total quarantines. A never seen disruption of the world economy and healthcare systems occurred as a consequence of these actions. [4] [5] [6] The first case detected in Latin America was on February 26th, 2020, in a 61-year-old individual from Brazil; the first death happened in Argentina on March 7 th , and 4 days later the World Health Organization (WHO) declared a pandemic. 7, 8 Finally, in June 2020, the WHO declared that the focus of the outbreak (epicenter) had shifted to Latin America. ( Figure 1) CV diseases are now the leading cause of morbidity and mortality worldwide and current global health policy goals include a 25% reduction in premature mortality from Non-Communicable Diseases (NCD) by 2025. 9 However, data from the Prospective Urban and Rural Epidemiological (PURE) study showed that in Latin American countries, secondary prevention drugs may be unavailable and/or unaffordable for a large proportion of communities and households. 10 Concerns about coronavirus infection in the community, as occurred in Europe and USA, led to a reduced number of visits and hospitalizations in patients with chronic NCD, such as CV diseases, diabetes, and cancer. 11, 12 J o u r n a l P r e -p r o o f A decrease in acute coronary syndromes and vascular hospitalizations was reported as well as an increase incidence of community cardiac arrests, stress cardiomyopathies (Takotsubo) and mortality due to acute myocardial infarction, compared with non-pandemic periods (the so called "Excess Mortality Rate"). [13] [14] [15] In this context, the question about how the COVID-19 pandemic has affected the life of non-infected cardiometabolic patients arises. 16 The current pandemic has raised important concerns in many aspects of the health care system , given the presumption that in parallel to the COVID-19 contagion curve there was another upward curve that was not being measured: the one related to CV events in non-COVID patients not properly attended in the population considered at risk. 17 The aim of this survey will be to collect information about the impact of the COVID-19 pandemic on the life of ambulatory non-infected cardiometabolic patients. No previous data on this field of study is available because this is an unprecedented scenario full of challenges and without immediate short-term solutions. This information could be of help for healthcare decision makers to prepare the appropriate policies to improve the care of these populations in hostile situations. The study population will include ambulatory adult patients with cardiometabolic diseases during regular cardiology follow-up in Spanish-speaking Latin American countries. Patients with prior CV (arterial hypertension, coronary artery disease, cardiomyopathies, valvular disease, or pericardial disease) or metabolic (metabolic syndrome, obesity, J o u r n a l P r e -p r o o f dyslipidemia, diabetes) history with no evidence or history of COVID-19; who voluntarily agree to participate in the study. Exclusion criteria (i) Patients less than 18 years-old, (ii) patients who have history, symptoms, signs, or suspicion of COVID-19 or absence of cardiometabolic disease, (iii) patients who could not provide consent. Patients will be informed about the objective of the survey and the anonymity of their responses. No identifiable personal data will be collected. Ethics approval was obtained from the Interamerican Society of Cardiology (IASC) Research Ethics Board. A cross-sectional online survey consisting of 38 questions will be developed using Google Forms (Mountain View, CA). Research staff will administer the questionnaire to patients and then will enter data on line. In accordance with government measures to limit population mobilization in some countries, the survey will be conducted either by face-toface visits or by phone or video chat in which case informed consent will be verbally taken. The survey will be divided into two parts; 1. Questions that examine patient´s demographic profile; 2. Questions that examine patient's behavior during the last 30 days The survey platform will be opened from June 15th until July 15th, 2020 for enrolling patients. Reminders will be emailed daily to maximize response rates, along with information about the progression of surveys by country. The survey has seven clusters of questions: It is crucial to determine some aspects that can affect behavior, such as age and gender. Equally important is to define the country in which patients live, since diet, physical activity or climate, can be substantially different. It is well known that environmental factors have an important influence on psychological disturbances like depression and stress. 18, 19 In terms of environmental and cultural factors the differences between the three regions are substantial. It is also relevant to highlight that some countries have received migratory flows especially from Europe, which have determined ethnic differences in comparison to other countries with larger native populations. The PURE study showed that socioeconomic status is associated with differences in risk factors for CV disease incidence and outcomes, including mortality. 20 According to this study, people with a lower level of education in low-and middle-income countries, such as the Latin American community, have higher incidence and mortality from CV diseases. 20 Aspects such as access to health services, treatments and vaccination against influenza and pneumonia will be essential to understand the true scenario of patients with cardiometabolic diseases during the COVID-19 pandemic. Patients will be characterized by their cardiometabolic history and the time of the last hospitalization due to CV events. It is well known that survivors of myocardial infarction or ischemic stroke, particularly diabetic patients, are at high risk for subsequent CV events and they need aggressive intervention for secondary prevention and comorbidities management. 21 An observational study performed in Mexico showed that more than 70% of the adult population living in areas with high social marginality, present diabetes, hypertension and obesity. 22 An analysis of different CV profiles and how COVID-19 pandemic affected their care will help supporting strategies to keep these patients within the healthcare system. Primary and secondary prevention guidelines remark the importance of healthy lifestyle to avoid CV events. 23 However, we have no evidence on the impact of quarantines on physical activity level or abrupt changes on diet, particularly in countries that adopted different intensity of confinement measures. On the other hand, data related to toxic habits is of J o u r n a l P r e -p r o o f utmost importance. The coronavirus pandemic has raised concerns that people who smoke may be at a greater risk of harm from infection given the impact of smoking on respiratory and immune function. 25 This group of questions includes one specifically aimed at establishing whether the patient has considered quitting tobacco as a concern of getting COVID-19 infection. Regarding alcohol intake, the survey will focus on the amount of current consumption and on the relation between consumption during home confinement period and prior stages. 27 There are concerns about increased consumption in some populations due to increments on psychological stress triggered by the interaction of financial difficulties, social isolation and uncertainty about the future. 28 Misperception of weight has repeatedly been documented among overweight and obese adults, and it has been hypothesized that in overweight and obese individuals this attitude may preclude the adoption of healthful attitudes and behaviors, perhaps as a result of lower weight loss motivation. 29 As in the case of toxic habits, a big question arises about how psychological stress and depression will influence appetite and diet disorders. 30 The imbalance between food intake J o u r n a l P r e -p r o o f and physical activity added to the poor perception of body weight, can lead to a change in the metabolic profile of overweight and obese patients in a relatively short period of time. Suboptimal adherence to medications taken chronically for secondary prevention of CV and metabolic diseases continues to burden the healthcare system despite the wellestablished benefits of prevention. 31 The number of pills per day, the access to healthcare systems, the availability of drugs and medical prescriptions are some potential barriers for appropriate adherence. 32 Given this adversity scenario, it is extremely valuable to evaluate the percentage of the population that is receiving their treatments according to medical indications. We are also interest in learning adherence to recommended immunization against influenza and pneumonia, since vaccines are particularly indicated in this group of patients. 33 The COVID-19 pandemic has brought not only the risk of death from infection but also unbearable psychological pressure. 34, 35 In the absence of antecedents of a global crisis of this magnitude in the current times, it is unknown the real impact in terms of stress and depression in our patients. Early detection of symptoms, and proper actions to provide tools for a better life during the pandemic may decrease post-pandemic long-term effects. 36 Statistical analysis Data will be collected in Google Forms. All statistical analysis will be performed using Stata v. 13.1 (Stata Corp LP, USA). Data will be described using means and standard deviations for continuous variables, and frequencies and percentages for categorical variables. Independent sample t-tests will be used to compare the normally distributed continuous variables, the Mann-Whitney U will be used for non-normally distributed J o u r n a l P r e -p r o o f appropriate) for categorical variables. A p value of less than 0.05 will be considered statistically significant. Multiple logistic regression models will be constructed for comparisons, OR and 95% CI will be provided. An unprecedented worldwide challenge that started about six months ago has transformed the world as we knew it. Healthcare systems have been particularly hit with this new condition that impacts our patients both physically and mentally. The impact on patients with NCDs is extremely important, and learning from their experiences during the pandemic, may help us delivering better care in the post-pandemic era. Particularly Latin American countries, and all the low-and middle-income ones, have an additional big challenge to control NCD's indicators. 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