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NCT Number: NCT07479186

Impact of Aortic Diseases on Quality of Life and Work Ability

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Roma, RM, 00168, Italy

Location status: Recruiting

Location contact

Ivo Iavicoli

CONTACT

[email protected]

0630155145

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivo Iavicoli, Prof

CONTACT

[email protected]

+ 39 0630155145

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Impact of Aortic Disease on Patients' Quality of Life and Working Capacity

Acronym: IMPACT-A

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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