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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic Group | Other | Participants who are suffer from unexplained left leg swelling. |
|
| Asymptomatic Group | Other | Participants who do not suffer from unexplained left leg swelling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duplex ultrasound | Diagnostic Test | Vascular ultrasound scan of the left common iliac vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Common Iliac Vein Diameter | The diameter measurement (in mm) of the left common iliac vein in adults referred to the vascular ultrasound department. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | Greater London | W6 8RF | United Kingdom |
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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).
Recruited from Vascular Outpatients clinic at Charing Cross Hospital between March 2024 and May 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symptomatic Group | Participants who suffer from unexplained left leg swelling. |
| FG001 | Asymptomatic Group | Participants who do not suffer from unexplained left leg swelling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symptomatic Group | Participants who suffer from unexplained left leg swelling. |
| BG001 | Asymptomatic Group | Participants who do not suffer from unexplained left leg swelling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of each participant recorded, mean age of the each group provided |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data could not be obtained from one participant in the symptomatic group due to non-visualization of the common iliac vein | Posted | Mean | Standard Deviation | Millimeters (mm) | Baseline |
|
On the study day / day of the ultrasound scan
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symptomatic Group | Participants who suffer from unexplained left leg swelling. |
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Limitation due to non-visualization of the CIV in some participants - In one participant no readings/data could be obtained, and in three participants only partial data could be obtained.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sophie Connolly | Imperial College Healthcare NHS Trust | 02033117322 | sophie.connolly1@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2023 | May 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D062108 | May-Thurner Syndrome |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D018616 | Ultrasonography, Doppler, Duplex |
| ID | Term |
|---|---|
| D018608 | Ultrasonography, Doppler |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Baseline |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| Years |
|
| Sex: Female, Male | Number of participants of each sex provided | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Participants asked to describe their ethnicity, a range of results provided | Count of Participants | Participants |
|
| BMI | Height and weight taken from each participant, BMI calculated | Mean | Full Range | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Number | 95% Confidence Interval | ICC - Reliability/descriptive statistic | Baseline |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Asymptomatic Group | Participants who do not suffer from unexplained left leg swelling | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003933 | Diagnosis |