Peripheral Vascular Disease and Health status

Recruiting

• Conditions: peripheral arterial disease; 10003184; 10003216

• Registration Number: NL-OMON37994
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 900

Inclusion Criteria

-Patient scheduled for non-cardiac vascular surgery
-Patient older than 18 years
-Patient have signed informed consent

Exclusion Criteria

-A life expectancy less than 12 months
-Presence of severe psychopathological comorbidities (e.g., psychosis, suicidal ideation)
-Severe cognitive impairment (Mini Mental Status Examination Score of 23 or lower) --Insufficient knowledge of the Dutch language.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is health status. Health status will be measured by<br /><br>the translated Dutch version of the PAQ, an disease-specific instrument for<br /><br>assessing health status in patients with PAD, and the Dutch version of the<br /><br>EQ-5D, a standardized, generic instrument for describing and valuing health.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Delirium (scores on the Delirium Scale > 12); mortality (both cardiac and<br /><br>non-cardiac); morbidity (i.e. a composite of rehospitalisation due to failed<br /><br>grafts). Data for these endpoints will be retrieved from the patients' medical<br /><br>records and assessed 2 years after surgery, including also the date of the<br /><br>event. </p><br>