Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07391293

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Thoracic Aortic Aneurysm (TAA) Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Vascular Diseases

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Policlinico San Donato

Milan, 20097, Italy

Location status: Recruiting

Location contact

Alessandro Pini, MD

CONTACT

[email protected]

+390252774705

About this study

Thoracic aortic aneurysms (TAA) present peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. The presence or absence of extra-aortic features determines whether TAADs are syndromic, associated with diseases affecting other systems and organs, or non-syndromic, with manifestations limited to the aorta. Life expectancy of patients withTAA has improved markedly in the last decades, but still remains lower than that of the general population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed onformed consent
  • Ability to speak, read and write in Italian

Exclusion criteria

-

Treatment and study plan

Journey to diagnosis

Other

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

Qestionnaires

Awareness and self-esteem, acceptance of the condition

Other

questionnaire related to the quality of life and self-care

psychological and physical well-being

Other

questionnaire to describe psychological and physical well-being.

Primary outcomes

  1. Journey to diagnosis

    Time frame: 15 months

    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.

  2. Quality of life, functional health and well-being

    Time frame: 15 months

    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.

  3. Awareness and self-esteem, acceptance of the condition

    Time frame: 15 months

    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.

  4. psychological and physical well-being

    Time frame: 15 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Pini, MD

CONTACT

[email protected]

+390252774705

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Acronym: PROM-1

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.