Aortic DiseasesIMPACT-ANCT07479186
Impact of Aortic Diseases on Quality of Life and Work Ability
An observational study of Aortic Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Aortic diseases encompass a wide spectrum of congenital and acquired, acute and chronic conditions, characterized by high clinical and prognostic complexity. The aorta plays a central role in blood flow distribution and hemodynamic modulation owing to its elastic properties, which become progressively impaired with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aortic Diseases
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2026to 30 Jun 2028
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic diseases under the care of the Complex Operative Unit of Vascular Surgery at Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who may be able to join
- Male and female patients with a confirmed diagnosis of aortic disease under the care of the Complex Operative Unit of Vascular Surgery of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
- Patients aged between 18 and 70 years.
Who cannot join
- Patients younger than 18 years or older than 70 years.
- Incomplete diagnostic workup.
- Patients who have undergone surgical procedures or experienced concomitant acute events unrelated to the aorta, with a predominant and recent functional impact, that make it impossible to isolate the effect of aortic disease on return to work.
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
Fondazione Policlinico Gemelli IRCCS
Roma, RM, 00168
Ivo Iavicoli, 0630155145, ivo.iavicoli@unicatt.it
About this study
Official title: Impact of Aortic Disease on Patients' Quality of Life and Working Capacity
Aortic diseases encompass a wide spectrum of congenital and acquired, acute and chronic conditions, characterized by high clinical and prognostic complexity. The aorta plays a central role in blood flow distribution and hemodynamic modulation owing to its elastic properties, which become progressively impaired with aging and in the presence of genetic or degenerative factors. Beyond clinical outcomes, aortic diseases lead to a marked reduction in health-related quality of life, psychological well-being, and functional capacity, with significant occupational and social consequences, thereby making multidisciplinary management necessary. This longitudinal observational study aims to systematically assess health-related quality of life, fatigue, psychological well-being, and work ability in patients with aortic diseases, with the objective of providing objective bases for occupational risk evaluation and promoting an interdisciplinary management model that integrates clinical, psychological, and work-related aspects, thereby supporting the maintenance or recovery of work functioning.
- Conditions
- Aortic Diseases
- Medical subject headings
- Aortic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Work Ability Index (WAI) score from baseline to 12 months in patients with aortic diseases
Work ability will be assessed using the Work Ability Index (WAI), a validated questionnaire composed of seven dimensions evaluating current work ability, work demands, health status, sickness absence, prognosis of future work ability, and psychological resources. The total WAI score ranges from 7 to 49 points, with higher scores indicating better work ability. The primary outcome is the change in total WAI score between baseline and the 12-month follow-up assessment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start31 Mar 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivo Iavicoli, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479186
- Sponsor's protocol ID
- 27010
- Acronym
- IMPACT-A
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aortic Disease on Patients' Quality of Life and Working Capacity
- ClinicalTrials.gov ID
- NCT07479186
- Acronym / sponsor ID
- IMPACT-A / 27010
- Conditions
- Aortic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Mar 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.
Aortic diseases encompass a wide spectrum of congenital and acquired, acute and chronic conditions, characterized by high clinical and prognostic complexity. The aorta plays a central role in blood flow distribution and hemodynamic modulation owing to its elastic properties, which become progressively impaired with aging and in the presence of genetic or degenerative factors. Beyond clinical outcomes, aortic diseases lead to a marked reduction in health-related quality of life, psychological well-being, and functional capacity, with significant occupational and social consequences, thereby making multidisciplinary management necessary. This longitudinal observational study aims to systematically assess health-related quality of life, fatigue, psychological well-being, and work ability in patients with aortic diseases, with the objective of providing objective bases for occupational risk evaluation and promoting an interdisciplinary management model that integrates clinical, psychological, and work-related aspects, thereby supporting the maintenance or recovery of work functioning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic diseases under the care of the Complex Operative Unit of Vascular Surgery at Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Key inclusion criteria (2 listed)
- Male and female patients with a confirmed diagnosis of aortic disease under the care of the Complex Operative Unit of Vascular Surgery of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
- Patients aged between 18 and 70 years.
Key exclusion criteria (3 listed)
- Patients younger than 18 years or older than 70 years.
- Incomplete diagnostic workup.
- Patients who have undergone surgical procedures or experienced concomitant acute events unrelated to the aorta, with a predominant and recent functional impact, that make it impossible to isolate the effect of aortic disease on return to work.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Work Ability Index (WAI) score from baseline to 12 months in patients with aortic diseases
Time frame: 12 months
Work ability will be assessed using the Work Ability Index (WAI), a validated questionnaire composed of seven dimensions evaluating current work ability, work demands, health status, sickness absence, prognosis of future work ability, and psychological resources. The total WAI score ranges from 7 to 49 points, with higher scores indicating better work ability. The primary outcome is the change in total WAI score between baseline and the 12-month follow-up assessment.
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 9 Jun 2026.
Related trials for Aortic Diseases
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
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.
Ivo Iavicoli, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Aortic Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 3 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 9 Jun 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 Ivo Iavicoli, Prof (+ 39 0630155145, ivo.iavicoli@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Work Ability Index (WAI) score from baseline to 12 months in patients with aortic diseases (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.