Actively Recruiting
The Frequency of Peripheral Arterial Disease in Patients with Deep Vein Thrombosis of the Lower Limbs
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-04
440
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the frequency of Peripheral Arterial Disease (PAD) and cardiovascular risk factors in patients with unprovoked Deep Vein Thrombosis (DVT) of the lower limbs. The study compares these patients with those having provoked DVT or cancer-related DVT. It also examines the relationship between the Ankle-Brachial Index (ABI) and Carotid Intima-Media Thickness (IMT) across these groups. This observational study is done at a single center with both retrospective and prospective designs, aiming to conclude by December 31, 2027. The study follows outpatients diagnosed with lower limb DVT who undergo ultrasound evaluations. Patients are grouped into unprovoked DVT, provoked DVT, and cancer-related DVT categories. PAD diagnosis includes measurements such as ABI and IMT, with specific criteria and classifications for these measures. The study gathers data through routine clinical evaluations, ultrasound, and Doppler exams, without any drug treatments or interventions involved. Participants attend the Vascular Day Service where their clinical history, ultrasound imaging, ABI, and IMT measurements are recorded. Researchers monitor the frequency of PAD, presence of atherosclerotic plaques, and the correlation between ABI, IMT, and DVT. Secondary outcomes include following thromboembolic recurrence and cardiovascular events during standard clinical care. The study includes adults diagnosed within the last six months and continues data collection until the study's end date.
CONDITIONS
Brief Title
The Frequency of Peripheral Arterial Disease in Patients with Deep Vein Thrombosis of the Lower Limbs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of unprovoked, provoked, or cancer-related deep vein thrombosis (DVT)
- Diagnosis of DVT in the lower limbs, both proximal and distal, confirmed by compression ultrasound within 6 months of diagnosis
- Ability to provide informed consent
You will not qualify if you...
- Diagnosis of upper limb DVT or DVT in other locations without lower limb involvement
- Diagnosis of superficial venous thrombosis (SVT) without concurrent lower limb DVT
- Diagnosis of DVT associated with central venous catheters (CVC)
- Presence of epithelial or basal cell carcinomas, due to low risk of deep vein thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 months after DVT diagnosis
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for compression ultrasound and clinical evaluation
Duration - Approximately 1 year
Participants undergo evaluation for Peripheral Arterial Disease (PAD), including measurements of Ankle-Brachial Index (ABI) and Intima-Media Thickness (IMT) of carotid and femoral arteries.
1 to 2 visits depending on assessments needed
Duration - Up to 1 year or more following diagnostic evaluation
Participants are monitored for recurrent thromboembolic and cardiovascular events according to standard clinical care.
Regular follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
IRCCS Azianda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
B
Benilde Cosmi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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