Genetic Aortic Diseases and Cardiovascular Complications. An Observational Survey of Risk Factors.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-60
SponsorIRCCS Policlinico S. Donato

About this trial

The aim of this observational study is to define the behavioural and cardiovascular risk factor profiles of patients with genetic aortopathies. The main questions it aims to answer are:

* How do the interconnections between lifestyle, stress, psychological condition, perception of illness, and state of health influence each other in this population? * Beyond traditional risk factors, additional emerging factors should be considered, including pregnancy-related complications, sedentary lifestyle, early menopause and depression. The interplay between eating disorders, lifestyle factors and autoimmune or inflammatory bowel diseases remains poorly understood.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

signed onformed consent

Ability to speak, read and write in Italian

Disqualifiers

None

Trial population

Patients with TAA either syndromic or non-syndromic followed at the Cardiovascular Genetic Centre, IRCCS Policlinico San Donato

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Journey to diagnosis

    Other intervention

    Questions relating to the course and experience/history of the disease from the onset of symptoms to confirmation of diagnosis; accessibility to referral facilities for treatment and follow-up.

  • Quality of life, functional health and well-being

    Other intervention

    Qestionnaires

  • Awareness and self-esteem, acceptance of the condition

    Other intervention

    questionnaire related to the quality of life and self-care

  • psychological and physical well-being

    Other intervention

    questionnaire to describe psychological and physical well-being.

Treatment groups

208 Participants
are divided into 1 treatment group
Group A: TAA4 interventions

Trial outcomes

Primary outcomes

1

Journey to diagnosis

The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.

Time frame
15 months
2

Quality of life, functional health and well-being

The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.

Time frame
15 months
3

Awareness and self-esteem, acceptance of the condition

The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.

Time frame
15 months
4

psychological and physical well-being

The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.

Time frame
15 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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