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NCT Number: NCT05715203

Aortic Stiffness in Patients With Genetic Aortopathies

The goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (TAA), either syndromic or non-syndromic. The main questions it aims to answer are:

* Stratification of aortic risk based on arterial stiffness; Compare measurements with morphological and haemodynamic features of the ascending thoracic aorta.

Participants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.

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Key information

Conditions

Rare Diseases Aneurysm Aneurysm, Ascending Aorta Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Stiffness Cardiovascular Diseases Connective Tissue Defect Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

Location status: Recruiting

Location contact

Alessandro Pini, MD

CONTACT

[email protected]

+390252774705

About this study

Recent studies have highlighted the role played by the aorta and the great arteries in the regulation of the blood pressure (BP) and peripheral blood flow. Similarly, the structural and functional alteration of the aortic wall having a genetic cause is highly associated with the onset of aneurysms, especially of the ascending aorta, for which it is essential to monitor the aortic stiffness, which is detectable through a non-invasive and non-radioactive method such as Pulse Wave Velocity (PWV). Despite literature studies correlating PWV in MFS, few evaluations of aortic stiffness in patients with syndromic TAA have been done and its potential correlations with other aneurysm markers.

Who can participate

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

Inclusion criteria

  • Subjects with AAT, either syndromic or non syndromic;
  • Signed informed consent

Exclusion criteria

  • Patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours;
  • Patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system;
  • Seropositivity to HIV, HCV, HBsAg and SARS-CoV-2;
  • Pregnancy

Treatment and study plan

Pulsotonometry

Device

Evaluation of arterial stiffness

Primary outcomes

  1. Pulse Wave Velocity

    Time frame: 18 months

    Statistic analysis will be performed using the Statistical Package for Social Science (SPSS for Windows; v20.0; SPSS, Chicago, Illinois, USA). Continuous variables will be expressed as mean ± Standard Deviation, while qualitative variables will be expressed as a percentage. Qualitative data will be compared using Fisher's test or Pearson's χ2 test, when appropriate. Continuous variables by t-test or analysis of variance normalized for covariates. Continuous variables will be correlated by simple or multiple linear regression

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

Collaborators

  • Istituto Auxologico Italiano

Registry information

Official study title

Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis

Acronym: PULSEWAVE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2023
Registry last updated
Sep 10, 2025

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.

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