May-Thurner Syndrome
Conditions
Brief summary
The goal of this feasibility/pilot study is to investigate whether or not vascular ultrasound can be used to aid the diagnosis of May Thurner Syndrome, in adult patients presenting to the vascular department with unexplained left leg swelling. The main research objective it aims to answer are: * The diameter variation of the left common iliac vein based on posture, using duplex ultrasound. * To determine inter- and intra-observer variation of the diameter measurement of the left common iliac vein using duplex ultrasound. Participants will have an ultrasound scan performed on their abdomen by three different clinical vascular scientists, and will have each scan performed whilst lying supine on an examination couch and again when the couch is tilted to 45 degrees. Researchers will compare the results of symptomatic patients to asymptomatic patients, to see if there is a difference in the diameter of the left common iliac vein between these two groups.
Interventions
DIAGNOSTIC_TESTDuplex ultrasound
Vascular ultrasound scan of the left common iliac vein
Sponsors
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has the capacity to consent * Participant is required to have a vascular ultrasound scan in the vascular ultrasound department * Participant is 18 years of age or older at the start of the study.
Exclusion criteria
* Previous iliac vein intervention or treatment for iliac vein disease * Previous diagnosis of iliac vein thrombus * Pregnancy * Unable to provide appropriate informed consent * The participant does not require a vascular ultrasound as part of their routine care * Under 18 years of age at the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Common Iliac Vein Diameter | Baseline | The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein | Baseline | The inter- and intra-operator variation of the diameter measurement of the left common iliac vein using duplex ultrasound, in adults referred to the vascular ultrasound department. Three different scientists took three measurements each of the common iliac vein. The results from the three scientists were compared to determine inter-operator variation, and the results from one scientist each were compared to determine intra-operator variation. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruited from Vascular Outpatients clinic at Charing Cross Hospital between March 2024 and May 2024.
Pre-assignment details
Questionnaire used to obtain a medical history taken from patient on morning of ultrasound scan, to determine which study group the participant should be allocated to (symptomatic or asymptomatic).
Participants by arm
| Arm | Count |
|---|---|
| Symptomatic Group Participants who suffer from unexplained left leg swelling. | 20 |
| Asymptomatic Group Participants who do not suffer from unexplained left leg swelling | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Symptomatic Group | Asymptomatic Group |
|---|---|---|---|
| Age, Continuous | 54 Years | 52 Years | 56 Years |
| BMI | 27 kg/m^2 | 29 kg/m^2 | 25 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Left Common Iliac Vein Diameter
The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department.
Time frame: Baseline
Population: Data could not be obtained from one participant in the symptomatic group due to non-visualization of the common iliac vein
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic Group | Left Common Iliac Vein Diameter | 7.5 Millimeters (mm) | Standard Deviation 2.9 |
| Asymptomatic Group | Left Common Iliac Vein Diameter | 7.7 Millimeters (mm) | Standard Deviation 2.3 |
Secondary
Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein
The inter- and intra-operator variation of the diameter measurement of the left common iliac vein using duplex ultrasound, in adults referred to the vascular ultrasound department. Three different scientists took three measurements each of the common iliac vein. The results from the three scientists were compared to determine inter-operator variation, and the results from one scientist each were compared to determine intra-operator variation.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symptomatic Group | Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein | 0.67 ICC - Reliability/descriptive statistic |
| Asymptomatic Group | Inter-and Intra-operator Variation of the Diameter Measurement of the Left Common Iliac Vein | 0.92 ICC - Reliability/descriptive statistic |