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

NCT06806540 | Recruiting

• 1 other identifier: TVP-AOP
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism; Peripheral Arterial Disease

Keywords

TVP; AOP

Outcome Measures

Primary Outcomes (3)

• Frequency of POA (Peripheral Obliterative Arteriopathy)

  Among the first-line non-invasive tests useful both for the diagnosis and surveillance of POA and for defining cardiovascular risk is the ABI (Ankle Brachial Index). The ABI is calculated as the ratio between the systolic pressure measured at the level of the posterior tibial artery (ankle) (or at the level of the pedal artery) of each limb and the systolic pressure measured bilaterally at the brachial artery (upper arm). The highest pressure value measured at each site is used for the calculation. The most commonly used method for measuring pressure involves the use of an 8 MHz CW Doppler probe. The primary outcome will be to assess the frequency of AOP defined by an ABI \< 0.90 in patients with unprovoked DVT compared to patients with provoked DVT and cancer-associated DVT.

  Through study completion, an average of 1 year

• Assess the presence of atherosclerotic plaques and the IMT (Intima-Media Thickness)of the common carotid artery

  Arterial color Doppler ultrasound is among the first-line non-invasive tests useful both for the diagnosis and surveillance of POA as well as for defining cardiovascular risk. In particular, color Doppler of the supra-aortic trunks allows the evaluation of atherosclerotic plaques and the IMT of the common carotid artery, which is widely used as a surrogate marker of diffuse atherosclerotic disease. Therefore, IMT and/or non-hemodynamic atherosclerotic plaques are assessed in patients with unprovoked DVT compared to patients with provoked DVT and cancer-associated DVT

  Through study completion, an average of 1 year

• Evaluate the correlation between ABI, IMT measurements, and DVT

  The aim is to evaluate the correlation between ABI, IMT measurements, and DVT, as some studies have shown a significant association between them, but the data in the literature are limited

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Monitoring Thromboembolic Recurrence and Cardiovascular Events in Patients Following Standard Clinical Care

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All outpatients, not admitted to the hospital, attending the Vascular Day Service of the SSD U.O. Angiology and Coagulation Disorders Unit at the Sant'Orsola Malpighi Polyclinic in Bologna will be evaluated from 01/10/2020 to 31/12/2026. At our center, these patients are typically managed according to the standard care pathway, which includes a clinical evaluation and an ultrasound examination in case of suspected deep vein thrombosis (pulmonary CT angiography in the case of suspected pulmonary embolism).

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azianda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Thromboembolism; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Benilde Cosmi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benilde Cosmi, MD

CONTACT

051 2142483; benilde.cosmi@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 4, 2025
• Study Start: June 10, 2021
• Primary Completion: June 5, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 4, 2025

Record last verified: 2024-11

Locations

IT (1)