Thoracic Aortic Aneurysm (TAA)PROM-1NCT07391293
Genetic Aortic Diseases and Cardiovascular Complications. An Observational Survey of Risk Factors.
An observational study of Thoracic Aortic Aneurysm (TAA), run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The aim of this observational study is to define the behavioural and cardiovascular risk factor profiles of patients with genetic aortopathies. The main questions it aims to answer are: How do the interconnections between lifestyle, stress, psychological condition, perception of illness, and state of health influence… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Thoracic Aortic Aneurysm (TAA)
- What is being tested?
- Journey to diagnosis, Quality of life, functional health and well-being and Awareness and self-esteem, acceptance of the condition
- How many people
- 208 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2025to May 2027
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with TAA either syndromic or non-syndromic followed at the Cardiovascular Genetic Centre, IRCCS Policlinico San Donato
Who may be able to join
- signed onformed consent
- Ability to speak, read and write in Italian
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Policlinico San Donato
Milan, 20097
Alessandro Pini, MD, +390252774705, alessandro.pini@grupposandonato.it
About this study
The aim of this observational study is to define the behavioural and cardiovascular risk factor profiles of patients with genetic aortopathies. The main questions it aims to answer are:
- How do the interconnections between lifestyle, stress, psychological condition, perception of illness, and state of health influence each other in this population?
- Beyond traditional risk factors, additional emerging factors should be considered, including pregnancy-related complications, sedentary lifestyle, early menopause and depression. The interplay between eating disorders, lifestyle factors and autoimmune or inflammatory bowel diseases remains poorly understood.
Read the detailed description
Thoracic aortic aneurysms (TAA) present peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. The presence or absence of extra-aortic features determines whether TAADs are syndromic, associated with diseases affecting other systems and organs, or non-syndromic, with manifestations limited to the aorta. Life expectancy of patients withTAA has improved markedly in the last decades, but still remains lower than that of the general population.
- Conditions
- Thoracic Aortic Aneurysm (TAA)
- Being tested
- Journey to diagnosis, Quality of life, functional health and well-being, Awareness and self-esteem, acceptance of the condition, psychological and physical well-being
- Keywords
- risk stratification, quality of life, rare disease, survey
- Medical subject headings
- Aortic Aneurysm, Thoracic, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey to diagnosisOther
Questions relating to the course and experience/history of the disease from the onset of symptoms to confirmation of diagnosis; accessibility to referral facilities for treatment and follow-up.
Quality of life, functional health and well-beingOther
Qestionnaires
Awareness and self-esteem, acceptance of the conditionOther
questionnaire related to the quality of life and self-care
psychological and physical well-beingOther
questionnaire to describe psychological and physical well-being.
| Study group | Role | What they receive |
|---|---|---|
| TAA | subjects with TAA aged between 14 and 60 years Receives: Other: Journey to diagnosis; Other: Quality of life, functional health and well-being; Other: Awareness and self-esteem, acceptance of the condition; Other: psychological and physical well-being |
What is being measured
The primary outcome is the main question the study is designed to answer.
Journey to diagnosis
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Measured: 15 months
Quality of life, functional health and well-being
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Measured: 15 months
Awareness and self-esteem, acceptance of the condition
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Measured: 15 months
psychological and physical well-being
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start6 May 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic Aneurysm (TAA)Studies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Pini, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391293
- Sponsor's protocol ID
- PROM-1
- Acronym
- PROM-1
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: PD will not or might not be shared according to the preliminary results
Publications
Saeyeldin AA, Velasquez CA, Mahmood SUB, Brownstein AJ, Zafar MA, Ziganshin BA, Elefteriades JA. Thoracic aortic aneurysm: unlocking the "silent killer" secrets. Gen Thorac Cardiovasc Surg. 2019 Jan;67(1):1-11. doi: 10.1007/s11748-017-0874-x. Epub 2017 Dec 4.
PubMed 29204794Udugampolage N, Caruso R, Panetta M, Callus E, Dellafiore F, Magon A, Marelli S, Pini A. Is SF-12 a valid and reliable measurement of health-related quality of life among adults with Marfan syndrome? A confirmatory study. PLoS One. 2021 Jun 9;16(6):e0252864. doi: 10.1371/journal.pone.0252864. eCollection 2021.
PubMed 34106976
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Aortic Diseases and Cardiovascular Complications. An Observational Survey of Risk Factors.
- ClinicalTrials.gov ID
- NCT07391293
- Acronym / sponsor ID
- PROM-1 / PROM-1
- Conditions
- Thoracic Aortic Aneurysm (TAA)
- Keywords
- risk stratification, quality of life, rare disease, survey
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to define the behavioural and cardiovascular risk factor profiles of patients with genetic aortopathies. The main questions it aims to answer are:
- How do the interconnections between lifestyle, stress, psychological condition, perception of illness, and state of health influence each other in this population?
- Beyond traditional risk factors, additional emerging factors should be considered, including pregnancy-related complications, sedentary lifestyle, early menopause and depression. The interplay between eating disorders, lifestyle factors and autoimmune or inflammatory bowel diseases remains poorly understood.
Detailed description
Thoracic aortic aneurysms (TAA) present peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. The presence or absence of extra-aortic features determines whether TAADs are syndromic, associated with diseases affecting other systems and organs, or non-syndromic, with manifestations limited to the aorta. Life expectancy of patients withTAA has improved markedly in the last decades, but still remains lower than that of the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAA | – | Other: Journey to diagnosis, Other: Quality of life, functional health and well-being, Other: Awareness and self-esteem, acceptance of the condition, Other: psychological and physical well-beingsubjects with TAA aged between 14 and 60 years |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with TAA either syndromic or non-syndromic followed at the Cardiovascular Genetic Centre, IRCCS Policlinico San Donato
Key inclusion criteria (2 listed)
- signed onformed consent
- Ability to speak, read and write in Italian
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Journey to diagnosisQuestions relating to the course and experience/history of the disease from the onset of symptoms to confirmation of diagnosis; accessibility to referral facilities for treatment and follow-up. | Other | TAA |
| Quality of life, functional health and well-beingQestionnaires | Other | TAA |
| Awareness and self-esteem, acceptance of the conditionquestionnaire related to the quality of life and self-care | Other | TAA |
| psychological and physical well-beingquestionnaire to describe psychological and physical well-being. | Other | TAA |
Primary outcome
Journey to diagnosis
Time frame: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Quality of life, functional health and well-being
Time frame: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Awareness and self-esteem, acceptance of the condition
Time frame: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
psychological and physical well-being
Time frame: 15 months
The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 29204794Saeyeldin AA, Velasquez CA, Mahmood SUB, Brownstein AJ, Zafar MA, Ziganshin BA, Elefteriades JA. Thoracic aortic aneurysm: unlocking the "silent killer" secrets. Gen Thorac Cardiovasc Surg. 2019 Jan;67(1):1-11. doi: 10.1007/s11748-017-0874-x. Epub 2017 Dec 4.
- Background: PubMed 34106976Udugampolage N, Caruso R, Panetta M, Callus E, Dellafiore F, Magon A, Marelli S, Pini A. Is SF-12 a valid and reliable measurement of health-related quality of life among adults with Marfan syndrome? A confirmatory study. PLoS One. 2021 Jun 9;16(6):e0252864. doi: 10.1371/journal.pone.0252864. eCollection 2021.
- Individual participant dataSharing planned: Undecided. PD will not or might not be shared according to the preliminary results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm (TAA), run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Pini, MD (+390252774705, alessandro.pini@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Journey to diagnosis (time frame: 15 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07391293, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.