NCT06806540 The Frequency of Peripheral Arterial Disease in Patients with Deep Vein Thrombosis of the Lower Limbs
| NCT ID | NCT06806540 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Thromboembolism |
| Study Type | OBSERVATIONAL |
| Enrollment | 440 participants |
| Start Date | 2021-06-10 |
| Primary Completion | 2024-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 440 participants in total. It began in 2021-06-10 with a primary completion date of 2024-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Benilde Cosmi, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06806540 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06806540 currently recruiting?
Yes, NCT06806540 is actively recruiting participants. Contact the research team at benilde.cosmi@unibo.it for enrollment information.
Where is the NCT06806540 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06806540 clinical trial?
NCT06806540 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Benilde Cosmi, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 440 participants.