Aortic Stiffness in Patients With Genetic Aortopathies

ConditionsRare Diseases Aortic Stiffness Connective Tissue Defect

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorIRCCS Policlinico S. Donato

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with AAT, either syndromic or non syndromic;

Signed informed consent

Disqualifiers

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

Trial population

Patients with ascending aortic aneurysms currently in follow.up at Cardiovascular Gentic Centre, IRCCS Policlinico San Donato.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Pulsotonometry
Device
Evaluation of arterial stiffness

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Syndromic TAA1 intervention

Group B: Non-syndromic TAA1 intervention

Trial outcomes

Primary outcomes

Pulse Wave Velocity

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

Time frame

18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Policlinico S. Donato

Lead sponsor

Istituto Auxologico Italiano

Collaborator

Source ClinicalTrials.gov

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