Impact of Aortic Diseases on Quality of Life and Work Ability

NCT07479186 | Recruiting

• 1 other identifier: 27010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with aortic diseases under the care of the Complex Operative Unit of Vascular Surgery at Fondazione Policlinico Universitario Agostino Gemelli IRCCS

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ivo Iavicoli, Prof

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivo Iavicoli, Prof

CONTACT

+ 39 0630155145; ivo.iavicoli@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-03

Locations

IT (1)