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Recruiting NCT05715203

Aortic Stiffness in Patients With Genetic Aortopathies

Observational Rare Diseases Aortic Stiffness Connective Tissue Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulsotonometry.
Who it may be relevant to
Registry conditions: Rare Diseases, Aortic Stiffness, Connective Tissue Defect. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis

Overview

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.

Detailed description

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.

Interventions

  • Device Pulsotonometry
    Evaluation of arterial stiffness

Primary outcome measures

  • Pulse Wave Velocity [Time frame: 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Policlinico San Donato — San Donato Milanese

Identifiers

NCT: NCT05715203 · Pulse Wave

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗