The Frequency of Peripheral Arterial Disease in Patients with Deep Vein Thrombosis of the Lower Limbs

Recruiting now

Conditions studied: Thromboembolism, Peripheral Arterial Disease

In brief

The aim of the study is to assess the frequency of Peripheral Arterial Disease (PAD) and cardiovascular risk factors in patients with unprovoked Deep Vein Thrombosis (DVT) of the lower limbs, comparing them with patients who have provoked DVT or cancer-related DVT. Additionally, the study aims to examine the association between the Ankle-Brachial Index (ABI) and Carotid Intima-Media Thickness (IMT) in the different patient groups. This is an observational, spontaneous, monocentric, non-pharmacological study conducted on outpatient, non-hospitalized patients diagnosed with lower limb DVT, including both unprovoked and provoked DVT, as well as cancer-related DVT. The patients are followed at the Vascular Day Service of the SSD U.O. Angiology and Coagulation Disorders Unit at the Sant'Orsola Malpighi Polyclinic in Bologna. The study has a retrospective design for patients with DVT diagnosed between October 1, 2020, and the date of project approval, and a prospective design for patients diagnosed with DVT after this date. The study is expected to conclude by December 31, 2027.

Key facts

Study ID

NCT06806540

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

440

Starts

2021-06-10

Expected to finish

2027-12-31

Last updated by the study team

2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Diagnosis of unprovoked, provoked, or cancer-related DVT
• Diagnosis of DVT in the lower limbs, both proximal and distal, subjected to compression ultrasound within 6 months of diagnosis
• Ability to provide informed consent

You may not qualify if…

• Diagnosis of upper limb DVT or DVT in other locations, if not concurrent with lower limb DVT
• Diagnosis of superficial venous thrombosis (SVT), if not concurrent with lower limb DVT
• Diagnosis of DVT associated with central venous catheters (CVC)
• Presence of epithelial or basal cell carcinomas, as they are associated with a low risk of deep vein thrombosis

Where it is running

• IRCCS Azianda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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