Dataset Information

Gut microbiota composition and arterial stiffness measured by pulse wave velocity: case-control study protocol (MIVAS study).

ABSTRACT:

Introduction

Intestinal microbiota is arising as a new element in the physiopathology of cardiovascular diseases. A healthy microbiota includes a balanced representation of bacteria with health promotion functions (symbiotes). The aim of this study is to analyse the relationship between intestinal microbiota composition and arterial stiffness.

Methods and analysis

An observational case-control study will be developed. Cases will be defined by the presence of at least one of the following: carotid-femoral pulse wave velocity (cf-PWV), Cardio-Ankle Vascular Index (CAVI), brachial ankle pulse wave velocity (ba or ba-PWV) above the 90^th percentile, for age and sex, of the reference population. Controls will be selected from the same population as cases. The study will be developed in Primary Healthcare Centres. We will select 500 subjects (250 cases and 250 controls), between 45 and 74 years of age. Cases will be selected from a database that combines data from EVA study (Spain) and Guimarães/Vizela study (Portugal).

Measurements

cf-PWV will be measured using the SphygmoCor system, CAVI, ba-PWV and Ankle-Brachial Index will be determined using VaSera device. Gut microbiome composition in faecal samples will be determined by 16S ribosomal RNA sequencing. Lifestyle will be assessed by food frequency questionnaire, adherence to the Mediterranean diet and IPAQ (International Physical Activity Questionnaire). Body composition will be evaluated by bioimpedance.

Ethics and dissemination

The study has been approved by 'Committee of ethics of research with medicines of the health area of Salamanca' on 14 December 2018 (cod. 2018-11-136) and the 'Ethics committee for health of Guimaraes' (Portugal) on 15 October 2019 (ref: 67/2019). All study participants will sign an informed consent form agreeing to participate in the study, in compliance with the Declaration of Helsinki and the WHO standards for observational studies. The results of this study will allow a better description of gut microbiota in patients with arterial stiffness.

Trial registration details

ClinicalTrials.gov, identifier NCT03900338.

SUBMITTER: Salvado R

PROVIDER: S-EPMC7880115 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background:Obesity is an important risk factor of cardiovascular disease (CVD). Atherosclerosis can be considered an important signal of CVD. Primary physicians can reduce the risk of CVD by preventing and treating obesity. Therefore, finding a tool to diagnose the association of obesity with arteriosclerosis is important. The association between obesity parameters and arterial stiffness remains controversial. To our knowledge, no previous studies reported the relationships between multiple new anthropometric parameters (a body shape index [ABSI], body round index [BRI], and visceral adiposity index [VAI]) and brachial-ankle wave velocity (ba-PWV) as an indicator of CVD risk, especially in the Korean population. Objective:To investigate the relationships between arterial stiffness (assessed using ba-PWV) and anthropometric parameters estimated on the basis of body mass index (BMI), waist circumference (WC), ABSI, BRI, and VAI, and to identify the indicators of obesity that best represents CVD risk. Methods:A total of 2,647 adults (1,474 men and 1,173 women) were recruited for this cross-sectional study. The correlations between the anthropometric indexes (BMI, WC, ABSI, BRI, and VAI) and mean ba-PWV were analyzed. A multivariate linear regression analysis was performed to evaluate the association between each anthropometric and the presence of arterial stiffness. Results:We investigated the relationships between the obesity parameters and ba-PWV by adjusting the covariates (age, diabetes mellitus [DM], hypertension [HTN], and smoking status) related to the mean ba-PWV. In the multivariate regression analysis, ABSI (men: ? =0.066, p<0.01; women: ? =0.087, p<0.001) and VAI (men: ? =0.067, p<0.01; women: ? =0.136, p<0.001) were found to be significantly correlated with the mean ba-PWV in both men and women in Korea. Conclusion:Among the new obesity indices, ABSI and VAI were found to be significantly associated with arterial stiffness, represented by the mean ba-PWV, in both men and women in Korea. These results suggest that ABSI and VAI may be convenient, highly cost-effective, and simple assessment tools for obesity and CVD risk in clinical practice.

Project description:BackgroundArterial Velocity-pulse Index (AVI) and Arterial Pressure-volume Index (API), measured by a brachial cuff, have been demonstrated to be indicative of arterial stiffness and correlated with the risk of cardiovascular events. However, the threshold values of AVI and API for screening increased arterial stiffness in the general population are yet to be established.MethodsThe study involved 860 subjects who underwent general physical examinations (M/F = 422/438, age 53.4 ± 12.7 years) and were considered to represent the general population in China. In addition to the measurements of AVI, API and brachial-ankle pulse wave velocity (baPWV), demographic information, arterial blood pressures, and data from blood and urine tests were collected. The threshold values of AVI and API were determined by receiver operating characteristic (ROC) analyses and covariate-adjusted ROC (AROC) analyses against baPWV, whose threshold for diagnosing high arterial stiffness was set at 18 m/s. Additional statistical analyses were performed to examine the correlations among AVI, API and baPWV and their correlations with other bio-indices.ResultsThe area under the curve (AUC) values in ROC analysis for the diagnosis with AVI/API were 0.745/0.819, 0.788/0.837, and 0.772/0.825 (95% CI) in males, females, and all subjects, respectively. Setting the threshold values of AVI and API to 21 and 27 resulted in optimal diagnosis performance in the total cohort, whereas the threshold values should be increased to 24 and 29, respectively, in order to improve the accuracy of diagnosis in the female group. The AROC analyses revealed that the threshold values of AVI and API increased markedly with age and pulse pressure (PP), respectively.ConclusionsWith appropriate threshold values, AVI and API can be used to perform preliminary screening for individuals with increased arterial stiffness in the general population. On the other hand, the results of the AROC analyses imply that using threshold values adjusted for confounding factors may facilitate the refinement of diagnosis. Given the fact that the study is a cross-sectional one carried out in a single center, future multi-center or follow-up studies are required to further confirm the findings or examine the value of the threshold values for predicting cardiovascular events.

Project description:ObjectivesCardiovascular disease is a major cause of morbidity and mortality in Antiphospholipid syndrome (APS). Arterial stiffness (ArS) has emerged as a predictor of future cardiovascular events in the general population. We aimed to assess ArS in patients with thrombotic APS versus diabetes mellitus (DM) and healthy controls (HC) and identify predictors of increased ArS in APS.MethodsArS was evaluated by carotid-femoral pulse wave velocity (cfPWV) and augmentation index normalized to 75 beats/min (AIx@75) using the SphygmoCor device. Participants also underwent carotid/femoral ultrasound for atherosclerotic plaque detection. We used linear regression to compare ArS measures among groups and assess ArS determinants in the APS group.ResultsWe included 110 patients with APS (70.9% female, mean age 45.4 years), 110 DM patients and 110 HC, all age/sex matched. After adjustment for age, sex, cardiovascular risk factors and plaque presence, APS patients exhibited similar cfPWV [β = -0.142 (95% CI -0.514, 0.230), p = 0.454] but increased AIx@75 [β = 4.525 (95% CI 1.372, 7.677), p = 0.005] compared with HC and lower cfPWV (p < 0.001) but similar AIx@75 (p = 0.193) versus DM patients. In the APS group, cfPWV was independently associated with age [β = 0.056 (95% CI 0.034, 0.078), p < 0.001], mean arterial pressure (MAP) [β = 0.070 (95% CI 0.043, 0.097), p < 0.001], atherosclerotic femoral plaques [β = 0.732 (95% CI 0.053, 1.411), p = 0.035] and anti-β2-glycoprotein I IgM positivity [β = 0.696 (95% CI 0.201, 1.191), p = 0.006]. AIx@75 was associated with age [β = 0.334 (95% CI 0.117, 0.551), p = 0.003], female sex [β = 7.447 (95% CI 2.312, 12.581), p = 0.005] and MAP [β = 0.425 (95% CI 0.187, 0.663), p = 0.001].ConclusionAPS patients exhibit elevated AIx@75 vs HC and similar to DM patients, indicating enhanced arterial stiffening in APS. Given its prognostic value, ArS evaluation may help to improve cardiovascular risk stratification in APS.