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Aortic Stiffness in Patients With Genetic Aortopathies (PULSEWAVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05715203
Recruitment Status : Not yet recruiting
First Posted : February 6, 2023
Last Update Posted : February 6, 2023
Sponsor:
Collaborator:
Istituto Auxologico Italiano
Information provided by (Responsible Party):
Alessandro Pini, IRCCS Policlinico S. Donato

Brief Summary:

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.


Condition or disease Intervention/treatment
Rare Diseases Aortic Stiffness Connective Tissue Defect Device: Pulsotonometry

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Aortic Stiffness in Patients With Genetic Aortopathies: Intervention Analysis
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : September 2024

Group/Cohort Intervention/treatment
Syndromic TAA
Subjets with clinical or genetic diagnosis of syndromic thoracic aortic aneurysms
Device: Pulsotonometry
Evaluation of arterial stiffness

Non-syndromic TAA
Subjets without clinical or genetic diagnosis of syndromic thoracic aortic aneurysms
Device: Pulsotonometry
Evaluation of arterial stiffness




Primary Outcome Measures :
  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 ± SD, 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with ascending aortic aneurysms currently in follow.up at Cardiovascular Gentic Centre, IRCCS Policlinico San Donato.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05715203


Contacts
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Contact: Alessandro Pini, MD +390252774705 alessandro.pini@grupposandonato.it

Locations
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Italy
IRCCS Policlinico San Donato
San Donato Milanese, Lombardia, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Alessandro Pini Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
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Responsible Party: Alessandro Pini, Principal Investigator, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT05715203    
Other Study ID Numbers: Pulse Wave
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandro Pini, IRCCS Policlinico S. Donato:
arterial stiffness
Ascending aortic aneurysm
pulse wave velocity
Additional relevant MeSH terms:
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Rare Diseases
Disease Attributes
Pathologic Processes