Vascular DiseasesANPSYSOMEVADNCT05472480
Anthropometric and Psychosocial Measurements in Vascular Disease
An observational study of Vascular Diseases and Psychosocial Problem, run by University of Catanzaro at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Psychosocial Problem, Social Functioning
- What is being tested?
- anthropometric and psychosocial measurements
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) admitted to Vascular Surgery Units of two hospitals linked with 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).
Who may be able to join
- age >18 years, both genders, being a patient with one type of vascular disease at the time of the study.
Who cannot join
- presence of more than one contemporary vascular disease at the time of the study, to avoid overlapping of concomitant vascular disease.
- presence of any illiteracy, or psychiatric issues that may impair understanding or self-administration of the questionnaire.
- malignancies.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Magna Graecia of Catanzaro
Catanzaro, 88100
Raffaele Serra, M.D., Ph.D., +3909613647380, rserra@unicz.it
Davide Costa
About this study
Official title: Association Between Anthropometric and Psychosocial Measurements in Vascular Disease
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.
Read the detailed 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.
- Conditions
- Vascular Diseases, Psychosocial Problem, Social Functioning
- Being tested
- anthropometric and psychosocial measurements
- Keywords
- sociology, vascular disease, anthropometric measurements, Psychosocial
- Medical subject headings
- Vascular Diseases, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthropometric and psychosocial measurementsDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Chronic Venous Disease Patients | Consecutive patients admitted to Vascular Surgery Units. Receives: Diagnostic Test: anthropometric and psychosocial measurements | |
| Carotid Stenosis Patients | Consecutive patients admitted to Vascular Surgery Units. Receives: Diagnostic Test: anthropometric and psychosocial measurements | |
| Abdominal Aortic Aneurysm Patients | Consecutive patients admitted to Vascular Surgery Units. Receives: Diagnostic Test: anthropometric and psychosocial measurements | |
| Peripheral Artery Disease Patients | Consecutive patients admitted to Vascular Surgery Units. Receives: Diagnostic Test: anthropometric and psychosocial measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of BMI
This measurement (reported in kg/m^2) will be related to the presence of vascular disease
Measured: 32 months
Analysis of waist circumference
This measurement (reported in cm) will be related to the presence of vascular disease
Measured: 32 months
Analysis of waist / hip ratio (WHR)
This ratio will be related to the presence of vascular disease
Measured: 32 months
Analysis of waist / stature (WSR)
This ratio will be related to the presence of vascular disease
Measured: 32 months
Analysis of ABSI "a body" score shape index
This index (range: from "Less than -0.868" to "Greater than +0.798") will be related to the presence of vascular disease
Measured: 32 months
Administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).
The BIDQ comprises seven items. Items 1-2 assess appearance concern and preoccupation, while item 3 measures perceived distress, and items 4-7 investigate functional impairment and avoidance
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jul 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, M.D., Ph.D., Study chair, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472480
- Sponsor's protocol ID
- E.R.ALL.2018.51
- Acronym
- ANPSYSOMEVAD
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Q, Wang XB, Yao Y, Ning CX, Chen XP, Luan FX, Zhao YL. Association between anthropometric measures and cardiovascular disease (CVD) risk factors in Hainan centenarians: investigation based on the Centenarian's health study. BMC Cardiovasc Disord. 2018 May 2;18(1):73. doi: 10.1186/s12872-018-0810-8.
PubMed 29716519Dhana K, Ikram MA, Hofman A, Franco OH, Kavousi M. Anthropometric measures in cardiovascular disease prediction: comparison of laboratory-based versus non-laboratory-based model. Heart. 2015 Mar;101(5):377-83. doi: 10.1136/heartjnl-2014-306704. Epub 2014 Dec 11.
PubMed 25502814Venkatrao M, Nagarathna R, Patil SS, Singh A, Rajesh SK, Nagendra H. A composite of BMI and waist circumference may be a better obesity metric in Indians with high risk for type 2 diabetes: An analysis of NMB-2017, a nationwide cross-sectional study. Diabetes Res Clin Pract. 2020 Mar;161:108037. doi: 10.1016/j.diabres.2020.108037. Epub 2020 Jan 29.
PubMed 32004696
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Anthropometric and Psychosocial Measurements in Vascular Disease
- ClinicalTrials.gov ID
- NCT05472480
- Acronym / sponsor ID
- ANPSYSOMEVAD / E.R.ALL.2018.51
- Conditions
- Vascular Diseases, Psychosocial Problem, Social Functioning
- Keywords
- sociology, vascular disease, anthropometric measurements, Psychosocial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic Venous Disease Patients | – | Diagnostic Test: anthropometric and psychosocial measurementsConsecutive patients admitted to Vascular Surgery Units. |
| Carotid Stenosis Patients | – | Diagnostic Test: anthropometric and psychosocial measurementsConsecutive patients admitted to Vascular Surgery Units. |
| Abdominal Aortic Aneurysm Patients | – | Diagnostic Test: anthropometric and psychosocial measurementsConsecutive patients admitted to Vascular Surgery Units. |
| Peripheral Artery Disease Patients | – | Diagnostic Test: anthropometric and psychosocial measurementsConsecutive patients admitted to Vascular Surgery Units. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) admitted to Vascular Surgery Units of two hospitals linked with 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).
Key inclusion criteria (1 listed)
- age >18 years, both genders, being a patient with one type of vascular disease at the time of the study.
Key exclusion criteria (3 listed)
- presence of more than one contemporary vascular disease at the time of the study, to avoid overlapping of concomitant vascular disease.
- presence of any illiteracy, or psychiatric issues that may impair understanding or self-administration of the questionnaire.
- malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anthropometric and psychosocial measurementsDifferent 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). | Diagnostic test | Abdominal Aortic Aneurysm Patients, Carotid Stenosis Patients, Chronic Venous Disease Patients, Peripheral Artery Disease Patients |
Primary outcome
Analysis of BMI
Time frame: 32 months
This measurement (reported in kg/m^2) will be related to the presence of vascular disease
Analysis of waist circumference
Time frame: 32 months
This measurement (reported in cm) will be related to the presence of vascular disease
Analysis of waist / hip ratio (WHR)
Time frame: 32 months
This ratio will be related to the presence of vascular disease
Analysis of waist / stature (WSR)
Time frame: 32 months
This ratio will be related to the presence of vascular disease
Analysis of ABSI "a body" score shape index
Time frame: 32 months
This index (range: from "Less than -0.868" to "Greater than +0.798") will be related to the presence of vascular disease
Administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).
Time frame: 32 months
The BIDQ comprises seven items. Items 1-2 assess appearance concern and preoccupation, while item 3 measures perceived distress, and items 4-7 investigate functional impairment and avoidance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 29716519Zhu Q, Wang XB, Yao Y, Ning CX, Chen XP, Luan FX, Zhao YL. Association between anthropometric measures and cardiovascular disease (CVD) risk factors in Hainan centenarians: investigation based on the Centenarian's health study. BMC Cardiovasc Disord. 2018 May 2;18(1):73. doi: 10.1186/s12872-018-0810-8.
- Background: PubMed 25502814Dhana K, Ikram MA, Hofman A, Franco OH, Kavousi M. Anthropometric measures in cardiovascular disease prediction: comparison of laboratory-based versus non-laboratory-based model. Heart. 2015 Mar;101(5):377-83. doi: 10.1136/heartjnl-2014-306704. Epub 2014 Dec 11.
- Background: PubMed 32004696Venkatrao M, Nagarathna R, Patil SS, Singh A, Rajesh SK, Nagendra H. A composite of BMI and waist circumference may be a better obesity metric in Indians with high risk for type 2 diabetes: An analysis of NMB-2017, a nationwide cross-sectional study. Diabetes Res Clin Pract. 2020 Mar;161:108037. doi: 10.1016/j.diabres.2020.108037. Epub 2020 Jan 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Serra, M.D., Ph.D. study chair
University Magna Graecia of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Psychosocial Problem, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Serra, M.D.; Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of BMI (time frame: 32 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472480, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.