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Clinical Trial Summary

This experimental study is to verify a possible correlation between vascular disease, and anthropometric, and psychosocial measurements. Consecutive patients with vascular diseases (Chronic Venous Disease, Carotid Stenosis, Abdominal Aortic Aneurysm, Peripheral Artery Disease) will be referred to Vascular Surgery Units of two hospitals linked to Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) to be evaluated. Since it is necessary to study the anthropometric measures and the psychosocial aspects, different types of measurements will be carried out in order to correlate them with the aforementioned vascular disease.


Clinical Trial Description

This is a cross sectional study with the aim analyze the association between the anthropometric and psychosocial measures in the following vascular disease: Chronic Venous Disease (CVD), Carotid Stenosis (CS) , Abdominal Aortic Aneurysm (AAA) , Peripheral Artery Disease (PAD). Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) referred to Vascular Surgery Units of two hospitals (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) will be evaluated. Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ). The data will be extrapolated from a prospective analysis on patients, by inserting in a Microsoft Excel database: demographic characteristics (age, sex); anthropometric parameters (height, weight, BMI, waist circumference WHR WSR ABSI); comorbidities, with particular reference to Diabetes mellitus, Dyslipidemia, Hypertension, CRI, coronary heart disease; smoking as a risk factor; the questionnaire for psychosocial aspects (BIDQ) on cumulative score (1-15); the vascular disease under examination. Population variables (age) and continuous outcomes (weight, age, BMI, waist circumference, WHR, WSR, ABSI, BIDQ) will be analyzed by Kruskal-Wallis test, while categorical variables (males, smokers, hypertension, diabetes, insulin-dependent diabetes, dyslipidemia, CAD, renal insufficiency) with Pearson's Chi-square test. The statistically significant outcomes will be subjected to sub-analysis with t-test, to identify the comparisons responsible for statistical significance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05472480
Study type Observational
Source University of Catanzaro
Contact Raffaele Serra, M.D.; Ph.D.
Phone +3909613647380
Email rserra@unicz.it
Status Recruiting
Phase
Start date July 1, 2019
Completion date August 1, 2022

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