Relationship of the Prime Diet Quality Score (PDQS) and Healthy Eating Index (HEI-2015) with depression and anxiety: a cross-sectional study.

BACKGROUND: Previous studies have suggested a significant association between diet quality and mental health. However, a limited number of studies have utilized the Prime Diet Quality Score (PDQS) to examine this association. Additionally, no study has yet compared the PDQS and Healthy Eating Index-2015 (HEI-2015) in terms of their association with depression and anxiety. AIM: This cross-sectional study aimed to investigate the association between diet quality, measured by the PDQS and HEI-2015, and the odds of depression and anxiety in adults. METHODS: This study utilized data from the LIPOKAP study, which was conducted between February 2018 and July 2019 in five cities in Iran. We included 1994 adults aged 18 and above who were selected through a multistage cluster sampling method. Participants completed a validated semiquantitative food frequency questionnaire (FFQ) to evaluate their dietary intake. The FFQ was used to calculate the PDQS and HEI-2015. Depression and anxiety levels were determined using the Hospital Anxiety and Depression Scale (HADS). RESULTS: The participants had a mean age of 39.79 ± 13.87 years, with females accounting for 1,041 (52.2%) of the total population. PDQS showed a significant inverse association with the odds of depression (OR = 0.45, 95% CI: 0.28-0.71) and anxiety (OR = 0.40, 95% CI: 0.25-0.62) in the fully adjusted model. Similarly, the highest quartile of HEI-2015 showed a significantly lower odds of depression (OR = 0.60, 95% CI: 0.40-0.90) and anxiety (OR = 0.62, 95% CI: 0.42-0.92) compared to the lowest quartile. CONCLUSION: Both PDQS and HEI-2015 were associated with a reduced risk of depression and anxiety. However, the PDQS demonstrated a stronger inverse association with these risks compared to the HEI-2015. This suggests that the PDQS could be a more beneficial dietary pattern for preventing depression and anxiety compared to HEI-2015. Further large-scale studies are required to confirm these findings.

Development of the first Iranian clinical practice guidelines for the diagnosis, treatment, and secondary prevention of acute coronary syndrome.

Background: This article introduces the first national guidelines for the management including diagnosis, treatment, and secondary prevention of acute coronary syndrome (ACS) in Iran. Materials and Methods: The members of the guideline development group (GDG) were specialists and experts in fields related to ACS and were affiliated with universities of medical sciences or scientific associations in the country. They carefully examined the evidence and clinical concerns related to ACS management and formulated 13 clinical questions that were sent to systematic review group who developed related evidence using Grade method. Finally the GDG developed the recommendations and suggestions of the guideline. Results: The first three questions in the guideline focus on providing recommendations for handling a patient who experience chest pain at home, in a health house or center, during ambulance transportation, and upon arrival at the emergency department (ED) as well as the initial diagnostic measures in the ED. Subsequently, the recommendations related to the criteria for categorizing patients into low, intermediate and high-risk groups are presented. The guideline addressed primary treatment measures for ACS patients in hospitals with and without code 247 or having primary percutaneous coronary intervention (PCI) facilities, and the appropriate timing for PCI based on the risk assessment. In addition, the most efficacious antiplatelet medications for ACS patients in the ED as well as its optimal duration of treatment are presented. The guideline details the recommendations for therapeutic interventions in patients with ACS and acute heart failure, cardiogenic shock, myocardial infarction with nonobstructive coronary arteries (MINOCA), multivessel occlusion, as well as the indication for prescribing a combined use of anticoagulants and antiplatelet during hospitalization and upon discharge. Regarding secondary prevention, while emphasizing the referral of these patients to rehabilitation centers, other interventions that include pharmaceutical and nonpharmacological ones are addressed, In addition, necessary recommendations for enhancing lifestyle and posthospital discharge pharmaceutical treatments, including their duration, are provided. There are specific recommendations and suggestions for subgroups, such as patients aged over 75 years and individuals with heart failure, diabetes, and chronic kidney disease. Conclusion: Developing guidelines for ACS diagnosis, treatment and secondary prevention according to the local context in Iran can improve the adherence of our health care providers, patients health, and policy makers plans.

First Iranian guidelines for the diagnosis, management, and treatment of hyperlipidemia in adults.

This guideline is the first Iranian guideline developed for the diagnosis, management, and treatment of hyperlipidemia in adults. The members of the guideline developing group (GDG) selected 9 relevant clinical questions and provided recommendations or suggestions to answer them based on the latest scientific evidence. Recommendations include the low-density lipoprotein cholesterol (LDL-C) threshold for starting drug treatment in adults lacking comorbidities was determined to be over 190 mg/dL and the triglyceride (TG) threshold had to be >500 mg/dl. In addition to perform fasting lipid profile tests at the beginning and continuation of treatment, while it was suggested to perform cardiovascular diseases (CVDs) risk assessment using valid Iranian models. Some recommendations were also provided on lifestyle modification as the first therapeutic intervention. Statins were recommended as the first line of drug treatment to reduce LDL-C, and if its level was high despite the maximum allowed or maximum tolerated drug treatment, combined treatment with ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors, or bile acid sequestrants was suggested. In adults with hypertriglyceridemia, pharmacotherapy with statin or fibrate was recommended. The target of drug therapy in adults with increased LDL-C without comorbidities and risk factors was considered an LDL-C level of <130 mg/dl, and in adults with increased TG without comorbidities and risk factors, TG levels of <200 mg/dl. In this guideline, specific recommendations and suggestions were provided for the subgroups of the general population, such as those with CVD, stroke, diabetes, chronic kidney disease, elderly, and women.

Perceived barriers of migrants and refugees to vaccinate their children against Measles and polio: a study in Iran.

BACKGROUND: This study examined the perceived barriers of migrants and refugees to vaccinating their children against measles and polio in Iran. METHODS: First, an instrument was developed and validated through several steps. Next, 1,067 parents who had not vaccinated their children against polio and measles or had delayed receiving any dose of these two vaccines until the age of 15 were selected from 16 provinces and completed the instrument. Finally, the data were analyzed. RESULTS: The results of the explanatory factor analysis showed that the perceived barriers affecting vaccination against polio and measles vaccines were categorized into five factors: low knowledge, negative attitude, communication challenges, lack of participation in vaccination programs, and problems related to migration and refugees. Additionally, the results indicated a significant difference in the mean score of perceived barriers based on participants' level of education, economic status, and nationality. CONCLUSION: The identified barriers may provide a perspective for developing effective efforts in this area. Interventions should focus on parents with low education and poor economic status.

The influential role of parents' socioeconomic status and diet quality on their children's dietary behavior: results from the LIPOKAP study among the Iranian population.

PURPOSE: There is a paucity of evidence regarding the influential factors on Iranian children's diet quality. To assess this issue, we explore the relationship between parental diet quality, socioeconomic status (SES), and nutritional knowledge with their children's diet quality using a cross-sectional sample of the Iranian population. METHODS: In this study, paired parents along with one of their children (aged 6-18 years old) who lived with them were included. Dietary intake was assessed using a food frequency questionnaire (FFQ) and diet quality was determined using an Alternative Healthy Eating Index-2010 (AHEI). Nutritional knowledge and SES were also explored using validated questionnaires. Multiple linear regression analysis was used and beta (ß) and corresponding 95% confidence interval (CI) were reported. RESULTS: After controlling for potential confounders, the parents' AHEI was significantly associated with their children's diet quality (ß = 12.34, 95% CI: 10.75, 13.93; P < 0.001). The nutritional knowledge of parents was significantly associated with children's AHEI after controlling for potential confounders (ß = 1.63, 95% CI: 0.14, 3.11; P = 0.032). Moreover, the parents' SES was inversely associated with the AHEI of children (ß=-3.76, 95% CI: -5.40, -2.11; P < 0.001); however, further adjustment for confounders attenuated this relationship (Model 3: ß = 0.87, 95% CI: -0.76, 2.34; P = 0.269). CONCLUSIONS: We found that the children's diet quality could be influenced by their parents' SES, nutritional knowledge, and diet quality. Our findings suggest that improving the nutritional knowledge of parents not only may improve the healthy eating pattern of parents but also could influence their children's diet quality.

The effect of magnesium sulfate on gene expression and serum level of inflammatory cytokines in coronary artery disease patients.

PURPOSE: To evaluate the effect of oral magnesium sulfate (MgSO4) on the gene expression and serum levels of inflammatory cytokines including TNF-α, IL-18, IL-1ß, IL-6, and IFN-γ in patients with moderate coronary artery disease (CAD). METHODS: 60 CAD patients were selected based on angiography findings and were randomly divided into two groups that received 300 mg/day MgSO4 (n = 30) or placebo (n = 30) for 3 months. Gene expression and serum levels of inflammatory cytokines were assessed. RESULTS: After 3 months of intervention, gene expression and serum levels of IL-18 and TNF-α in the MgSO4 group were significantly less than the placebo group (P < 0.05). However, no significant difference in gene expression and serum levels of IL-1ß, IL-6, and IFN-γ was observed between the two groups (P > 0.05). In addition, within group analysis demonstrate that Mg-treatment significantly decrease serum level of TNF-α and IL-18 as compared to pretreatment. CONCLUSION: The results of our study demonstrate that 3-month magnesium sulfate administration (300 mg/day) to CAD patients could significantly decrease serum concentration and gene expression levels of IL-18 and TNF-α. Our findings support the potential beneficial effect of magnesium supplementation on alleviating CAD complications through modulating inflammatory cytokines.

Magnesium Supplementation Affects the Expression of Sirtuin1, Tumor Protein P53 and Endothelial Nitric Oxide Synthase Genes in Patients with Atherosclerosis: A Double-Blind, Randomized, Placebo-Controlled Trial.

Magnesium seems to play a role in improving cardiovascular function, but its exact mechanism is unknown. In this study, we hypothesized that magnesium could modulate the expression of genes involved in atherosclerosis. The aim of the present investigation was to evaluate the effect of magnesium sulfate on the expression of sirtuin1 (SIRT1), tumor protein p53 (TP53), and endothelial nitric oxide synthase (eNOS) genes in patients with atherosclerosis. This study was a placebo-controlled double-blind randomized clinical trial on 56 patients with angiographically proven atherosclerosis. Participants were randomly divided into two groups receiving 300 mg/day magnesium sulfate (n = 29) and placebo (n = 27) for three months (following up every month). Fasting blood samples were taken before and after the intervention and total RNA was extracted and used to evaluate the expression level of SIRT1, TP53, and eNOS genes by Real-Time PCR. The expression of eNOS gene was significantly increased (P < 0.0001) and the expression of TP53 gene was decreased (P = 0.02) in the magnesium sulfate group compared to the placebo group. But SIRT1 gene expression was not significantly different between the two groups. Our findings demonstrate that magnesium sulfate supplementation may have a protective role against the progression of atherosclerosis through upregulation of eNOS and downregulation of TP53 gene. Trial registration: This present clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code of "IRCT20151028024756N3", https://www.irct.ir/trial/29097?revision=114102. Registered on 16 December 2019.

Efficacy and safety of favipiravir plus interferon-beta versus lopinavir/ritonavir plus interferon-beta in moderately ill patients with COVID-19: A randomized clinical trial.

Favipiravir (FVP), lopinavir/ritonavir (LPV/RTV), and interferon-beta (INF-beta) are considered as potential treatments for COVID-19. We examined the efficacy and safety of FVP and INF-beta compared to LPV/RTV and INF-beta combinations for the treatment of SARS-CoV-2. It was a single-center randomized clinical trial. Eligible patients were randomized to receive FVP plus INF-beta versus LPV/RTV plus INF-beta. The primary endpoint was the viral clearance after seven days of randomization. ICU admission, length of stay (LOS) in hospital, in-hospital mortality, and the incidence of adverse events were also measured. This trial was registered on the Iranian Registry of Clinical Trials (IRCT20200506047323N3). Patients were randomly allocated to the FVP (n = 33) and LPV/RTV (n = 33) groups. The viral clearance on Day seven was not significantly different between the FVP (31.1%) and the LPV/RTV groups (16.1%). The rate of ICU admission and likewise the in-hospital mortality in the FVP group (12.5% and 6.3%, respectively) were similar to the LPV/RTV groups (19.4% and 19.4%, respectively). The median LOS in the hospital was also not different (6.8 days [interquartile range; IQR = 5.0-11.0] in the FVP and (8.0 days [IQR = 5.5-12.5]) in LPV/RTV groups (p = 0.140). Adverse events were observed in 25.0% of FVP and 32.3% of LPV/RTV groups. The combination therapy with FVP did not exert a higher efficacy compared to the combination regimen of LPV/RTV. However, both treatment regimens demonstrated a mild profile of adverse events.

Preparation and pre-clinical evaluation of flagellin-adjuvanted NOM vaccine candidate formulated with Spike protein against SARS-CoV-2 in mouse model.

From December 2019, the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was started as a cluster of pneumonia cases in Wuhan, Hubei Province, China. The disturbing statistics of SARS-CoV-2 promoted scientists to develop an effective vaccine against this infection. NOM protein is a multi-epitope protein that designed based on Nucleocapsid, ORF3a, and Membrane proteins of SARS-CoV-2. Flagellin is a structural protein that binds to the Toll-like receptor 5 and can enhance the immune response to a particular antigen. In this study, NOM protein as vaccine candidate was linked to the carboxyl and amino terminals of flagellin adjuvant derived from Salmonella enterica subsp. enterica serovar Dublin. Then, informatics evaluations were performed for both NOM protein and NOM protein linked to flagellin (FNOM). The interaction between the NOM and FNOM proteins with the TLR5 were assessed using docking analysis. The FNOM protein, which compared to the NOM protein, had a more suitable 3D structure and a stronger interaction with TLR5, was selected for experimental study. The FNOM and Spike (S) proteins expressed and then purified by Ni-NTA column as vaccine candidates. For analysis of immune response, anti-FNOM and anti-S proteins total IgG and IFN-γ, TNF-α, IL-6, IL-10, IL-22 and IL-17 cytokines were evaluated after vaccination of mice with vaccine candidates. The results indicated that the specific antisera (Total IgG) raised in mice that received FNOM protein formulated with S protein were higher than mice that received FNOM and S proteins alone. Also, IFN-γ and TNF-α levels after the spleen cells stimulation were significantly increased in mice that received the FNOM protein formulated with S protein compared to other groups. Immunogenic evaluations showed that, the FNOM chimeric protein could simultaneously elicit humoral and cell-mediated immune responses. Finally, it could be concluded that the FNOM protein formulated with S protein could be considered as potential vaccine candidate for protection against SARS-CoV-2 in the near future.

Association between ultra-processed foods consumption and micronutrient intake and diet quality in Iranian adults: a multicentric study.

OBJECTIVE: To identify ultra-processed foods (UPF) contribution to daily energy and nutrient intake in Iranians and examine whether UPF intake is associated with nutrient profile and diet quality. DESIGN: In this cross-sectional study, a validated FFQ was used to evaluate usual dietary intake over the preceding year. NOVA system was applied to categorise foods based on their levels of processing. Diet quality was evaluated using the nutrient adequacy ratio (NAR), Nutrient Rich Food Index (NRF) and hybrid nutrient density. SETTING: The LIPOKAP study conducted in five cities of Iran (Isfahan, Birjand, Bandar Abbas, Kermanshah and Shahrekord). PARTICIPANTS: A total of 1994 adults aged ≥18 years were recruited using stratified multistage random cluster sampling method. RESULTS: UPF were responsible for 8·5 % of daily energy intake. In the adjusted model, UPF consumption was inversely associated with carbohydrate, protein, refined and whole grains, fibre, fruit and meat, but was positively linked to energy, total fat, saturated and trans fatty acids and cholesterol. Compared with those in the lowest tertile, individuals in the highest tertile of UPF had smaller NAR for Ca, Mg, Zn, Fe, phosphorus, thiamin, niacin, folate and vitamin C. Both NRF and hybrid nutrient density decreased when the share of daily energy intake from UPF increased. CONCLUSION: The higher consumption of UPF is associated with poorer diet quality and lower nutrient intake. It is recommended that UPF be replaced with minimally processed foods to improve diet quality and nutrient profile.

Predicting the COVID-19 vaccine receive intention based on the theory of reasoned action in the south of Iran.

BACKGROUND: Vaccination against Covid 19 disease was based on rational practice theory. One of the most effective methods to control the COVID-19 pandemic is extensive vaccination coverage in the shortest time. The relevant beliefs and predictors of COVID-19 vaccine and the barriers to and facilitators of receiving COVID-19 vaccine should be identified. Individuals' intention to receive COVID-19 and the effective factors are of an utmost importance. This study aimed to predict intention to receive COVID-19 vaccine in the South of Iran. METHODS: This cross-sectional study was performed over a period of 2 months (May 2021 to July 2021) in 4 southern provinces in Iran. The study population of this study included people over 18 years of age who did not receive the COVID-19 vaccine. The online questionnaire was used to collect data. We recruited participants through a self-selection sampling method and posted the online survey link. The questionnaire had two parts: demographic information and Theory of Reasoned Action (TRA) questions. All statistical calculations and hypotheses tests were performed using SPSS21 and Amos21 software and the significance level was considered 0.05. RESULTS: A total number of 2556 people participated in this study with a mean age of 37.76 (10.7) of years (Age Range = 18-75). The findings showed that attitudes and subjective norms and the use of social media predict the intention to receive COVID-19 vaccine. SEM showed that attitude (ß = 0.596, P < 0.001), subjective norms (ß = 0.265, P < 0.001) were significant predictors of vaccination intention. In this study, 78% of people were willing to receive the vaccine when they were officially allowed to. CONCLUSION: According to the results of the study, it is suggested to strengthen positive attitudes and subjective norms about the importance of COVID-19 vaccination as well as using social media to inform the community in order increase the intention to vaccinate COVID-19 and increase vaccine coverage.

Priority setting in cardiovascular research in Iran using standard indigenous methods.

Background: Determining cardiovascular disease (CVD) research priorities is essential given the high burden of these diseases, limited financial resources, and competing priorities. This study aimed to determine the research priorities in CVD field in Iran using standard indigenous methods. Materials and Methods: An extensive search was done in relevant international and national studies. Then, an indigenous standard multistage approach based on multicriteria decision analysis steps was adapted to local situation and implemented. This process included forming a working group of experts in priority setting methodology, identifying the context and prioritization framework, discussing the methodology with the National Network of CVD Research (NCVDR) members who ultimately determined the priority research topics, weighted topics criteria, ranked topics, and reviewed all determined research priorities for final report. Results: Thirteen cardiovascular research priorities were determined by the NCVDR members. The first five priorities based on their scores include studies in hypertension, prevention and control of ischemic heart disease (IHD) and its risk factors, burden of IHD, Registration of CVDs, and COVID-19 and CVDs. Conclusion: Cardiovascular research priorities were determined using a standard indigenous approach by national experts who are the NCVDR members. These priorities can be used by researchers and health decision makers.

Lack of association between serum IL-25 levels and acute coronary syndrome: a preliminary study.

Purpose    Here, for the first time, the possible association between IL-25 and the risk of acute coronary syndrome (ACS) in Iranian patients was investigated.Material and methods    In this study, serum IL-25 concentrations were measured with an enzyme-linked immunosorbent assay in 88 ACS patients, 40 stable angina pectoris (SAP) patients, and 50 healthy control subjects.Results    No significant differences in IL-25 concentrations were observed between SAP (340±168 ng / l), ACS (330±151 ng / l), and control (302±135 ng / l) groups (p=0.5), nor was there a difference among patients with 1, 2, or 3 vessel disease in the SAP and ACS groups. Linear regression analyses revealed that IL-25 was not correlated with coronary artery disease risk factors. Biochemical and demographic variables did not differ significantly among IL-25 quartiles.Conclusion    Despite previous murine and human studies showing a protective role of IL-25 in atherosclerosis, our results revealed that IL-25 does not have potential implications for atherosclerosis development and management in humans.

Magnesium Sulfate Administration in Moderate Coronary Artery Disease Patients Improves Atherosclerotic Risk Factors: A Double-Blind Clinical Trial Study.

Magnesium (Mg) deficiency is known to promote vascular and cardiac dysfunctions such as atherosclerosis. This study investigated the effect of oral MgSO4 therapy to improve lipid profile and serum oxidized LDL level and its receptor (LOX1) in moderate coronary atherosclerotic patients. In this randomized double-blind placebo-controlled clinical trial study, 64 patients with moderate coronary artery disease were selected according to angiography findings. Participants were divided into 2 groups including Mg-treated (n = 32) and placebo (n = 32) The patients received either placebo or MgSO4 supplement capsule, containing 300 mg MgSO4 for 6 months on a daily basis. Lipid profile, HbA1c, 2h postprandial (2hpp) blood glucose, fasting blood sugar, serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), oxidized low-density lipoprotein, and lectin-like ox-LDL receptor 1 (LOX1) concentrations were measured at baseline and every 3 months. HbA1c, serum LOX1, and oxidized low-density lipoprotein concentrations were significantly lower in the Mg-treated group than the placebo group 3 months after MgSO4 administration. 2hpp, serum low-density lipoprotein cholesterol, SGPT, SGOT levels, and HbA1c levels significantly improved in the Mg-treated group compared with the placebo-received group. Overall, the results of this study showed that magnesium treatment improved some of the major risk factors of atherosclerosis. According to the results of liver function tests (SGOT and SGPT), magnesium therapy seems to be safe in patients with moderate atherosclerotic plaque. Therefore, it is suggested that magnesium to be used along with other atherosclerosis control drugs.

Endothelial Nitric Oxide Synthase Gene Polymorphisms (- 922A > G, - 786 T > C, Intron 4 b/a VNTR and 894 G > T) and Essential Hypertension: An Association Study with Haplotypes Analysis.

Endothelial Nitric Oxide Synthase (eNOS) is an indispensable regulator of blood pressure through producing Nitric Oxide (NO). There is some evidence to suggest that eNOS gene polymorphisms are associated with Essential Hypertension (EHT). In this study, the potential association between eNOS 4a/4b, A922G, G894T, T786C gene polymorphisms and EHT as individual risk factors and as haplotypes are examined in the southern population of Iran (Bandar-Abbas). In this study, 200 EHT patients and 200 normotensive subjects which were matched for age and sex were included. Genotyping was performed by either utilizing Polymerase Chain Reaction (PCR) or PCR followed by Restriction Fragment length Polymorphism (RFLP) method. Our results demonstrated statistically significant associations between T786C, G894T, and 4a/4a and EHT (p < 0.05); however, A922G had no significant association with EHT (p > 0.05). Haplotype analysis also suggested that - 786C/- 922A/4a, - 786C/- 922A/4b and - 786C/- 922G/4a haplotypes were more frequent in EHT group than control group, hypothesizing a positive association with EHT. The present study has identified that the eNOS genetic variations are associated with EHT in southern population of Iran (Bandar-Abbas). These findings also suggested that a number of haplotypes of eNOS gene may be a driving factor for EHT susceptibility in respected population.

The association between soft drinks consumption and risk of mental disorders among Iranian adults: The LIPOKAP study.

OBJECTIVE: With rising demand for soft drinks (SDs) in low-income countries, studies examining mental disorders in relation to SDs are rather scarce. Therefore, we aimed to explore this association in a sample of Iranian adults. METHODS: This cross-sectional study was carried out within the framework of the multi-centric LIPOKAP project, with 1970 Iranian healthy adults. Dietary intake and symptoms of depression and anxiety were collected using validated, Persian versions of a food frequency questionnaire and a Hospital Anxiety and Depression Scale (HADS), respectively. Artificial juices were considered fruit-flavored carbonated sugar beverages, sugar-sweetened beverages (SSB) included fruit-flavored carbonated sugar beverages and carbonated colas, and soft drinks included SSB and drinks containing non-nutritive sweeteners. RESULTS: The mean age of the participants was 39.8 ± 13.9 years. Compared to lower intake, higher intake of SDs (OR = 1.30, 95 % CI: 1.01, 1.69; P = 0.041), SSBs (OR = 1.30, 95 % CI: 1.00, 1.67; P = 0.045) and artificial juice (OR = 1.63, 95 % CI: 1.24, 2.13; P < 0.001) was associated with higher risk of depression in adjusted model. These associations were sex-specific and more evident in males. No significant association was found between any of the drinks and anxiety risk except for artificial juice in men which was directly associated with anxiety risk (OR = 1.66, 95 % CI: 1.06, 2.61; P = 0.028). CONCLUSION: This study found a positive association between SDs, SSBs and artificial juice and depression, but not anxiety. These associations varied between men and women. Prospective cohort studies are warranted to confirm our results and reveal the causal relationship.

Audit and quality assessment of national persian registry of cardiovascular disease(N-PROVE) in terms of comorbidities, angiography, and angioplasty characteristics in Iran.

BACKGROUND: The National Persian Registry of Cardiovascular Disease (N-PROVE) has been established to provide a comprehensive database of cardiovascular diseases in the Iranian community for further investigations and to develop national guidelines for the diagnosis, treatment, and prevention of cardiovascular disease (CVD). As with most clinical registries, a quality control audit is necessary to ensure a comprehensive and accurate registry; the current study aims to assess the validity and quality of the N-PROVE/Angiography/Percutaneous Coronary Intervention (PCI) registry. METHODS: The current cross-sectional quality assessment study serves as an example of data quality assessment in N-PROVE on a sample of patients registered in the N-PROVE/Angiography/PCI registry since 2020. Accordingly, data of 194 patients, including comorbidities, angiography, and angioplasty characteristics, were collected from the N-PROVE/Angiography/PCI registry as the main database and reevaluated by a panel consisting of a cardiologist and two coronary intervention fellowships as a test database. RESULTS: The quality control of the population-based healthcare database, the N-PROVE/PCI, revealed that the average error rate in terms of comorbidities, angiography characteristics, angioplasty characteristics, and in total were 3.8%, 2.3%, 3%, and 3.03%, respectively. CONCLUSION: According to the findings of this study, the N-PROVE/PCI registry had an average error of less than 4% in the assessed dimensions, including comorbidities, angiography, and angioplasty characteristics. Therefore, this registry appears valid and may be used for contemporary epidemiological studies.

The relationship between a plant-based diet and mental health: Evidence from a cross-sectional multicentric community trial (LIPOKAP study).

BACKGROUND: Dietary patterns emphasizing plant foods might be neuroprotective and exert health benefits on mental health. However, there is a paucity of evidence on the association between a plant-based dietary index and mental health measures. OBJECTIVE: This study sought to examine the association between plant-based dietary indices, depression and anxiety in a large multicentric sample of Iranian adults. METHODS: This cross-sectional study was performed in a sample of 2,033 participants. A validated food frequency questionnaire was used to evaluate dietary intakes of participants. Three versions of PDI including an overall PDI, a healthy PDI (hPDI), and an unhealthy PDI (uPDI) were created. The presence of anxiety and depression was examined via a validated Iranian version of the Hospital Anxiety and Depression Scale (HADS). RESULTS: PDI and hPDI were not associated to depression and anxiety after adjustment for potential covariates (age, sex, energy, marital status, physical activity level and smoking). However, in the crude model, the highest consumption of uPDI approximately doubled the risk of depression (OR= 2.07, 95% CI: 1.49, 2.87; P<0.0001) and increased the risk of anxiety by almost 50% (OR= 1.56, 95% CI: 1.14, 2.14; P= 0.001). Adjustment for potential confounders just slightly changed the associations (OR for depression in the fourth quartile= 1.96; 95% CI: 1.34, 2.85, and OR for anxiety in the fourth quartile= 1.53; 95% CI: 1.07, 2.19). CONCLUSIONS: An unhealthy plant-based dietary index is associated with a higher risk of depression and anxiety, while plant-based dietary index and healthy plant-based dietary index were not associated to depression and anxiety.

A Cardiovascular Risk Assessment Model According to Behavioral, Psychosocial and Traditional Factors in Patients With ST-Segment Elevation Myocardial Infarction (CRAS-MI): Review of Literature and Methodology of a Multi-Center Cohort Study.

This study aims to provide a comprehensive risk-assessment model including lifestyle, psychological parameters, and traditional risk factors to determine the risk of major adverse cardiovascular events (MACE) in patients with the first acute ST-segment elevation myocardial infarction episode. Patients were recruited from new hospital admissions of acute ST-segment elevation myocardial infarction and will be followed up to 3 years. Clinical and paraclinical characteristics, lifestyle, psychological, and MACE information are collected and will be used in the risk-assessment model. Totally, 1707 patients were recruited (male: 81.4%, mean age: 56.60 ± 10.34). Primary percutaneous coronary intervention was the most prevalent type of coronary revascularization (81.9%). In case of baseline psychological characteristics, mean depression score was 5.40 ± 4.88, and mean distress score was 7.64 ± 5.08. A comprehensive approach, focusing on medical, lifestyle, and psychological factors, will lead to better identification of cardiovascular disease patients at risk of developing MACE through comprehensive risk-assessment models.

Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial.

Importance: The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown. Objective: To evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults. Design, Setting, and Participants: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021. Interventions: In cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection. Main Outcomes and Measures: The primary outcome was polymerase chain reaction-confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed. Results: In cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths. Conclusions and Relevance: In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19-related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price. Trial Registration: isrctn.org Identifier: IRCT20210303050558N1.