Rare Diseases Clinical Trial
— PULSEWAVEOfficial title:
Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis
The goal of this observational study is to study arterial stiffness in patients with ascending aortic aneurysms, either syndromic or non syndromic. The main questions it aims to answer are: - Stratification of aortic risk based on Pulse Wave Velocity; - Compare measurements with morphological and hemodynamic features of the ascending thoracic aorta. Participants will be asked to undergo non invasive evaluation of blood pressure and arterial pulse wave velocity.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | September 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Donato | San Donato Milanese | Lombardia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Donato | Istituto Auxologico Italiano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ?2 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 | 18 months |
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