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The goal of this study is to examine in vivo thrombosis characteristics with ultrasound shear wave elastography (SWE) and determine the relationship with thrombus resolution and postthrombotic syndrome (PTS) in patients with acute proximal Deep Vein Thrombosis (DVT).
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| Measure | Description | Time Frame |
|---|---|---|
| Thrombus Resolution | Ultrasound images of lower extremity DVTs comparing the initial diagnostic image of thrombus to a subsequent study performed after 3 months of anticoagulation.The lower extremity venous system is divided into 12 segments. Each vein segment will be analyzed on initial ultrasound and recorded 0 (no DVT), 1 (non-occlusive DVT), or 2 (occlusive DVT). The follow up ultrasound will be analyzed per vein segment and recorded as no residual thrombus, minimal chronic post-thrombotic changes, > 50% resolution, < 50% resolution, near occlusive DVT, no change, and progressive DVT. | 3 Months after diagnosis of DVT. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-thrombotic syndrome | Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms. | 6 months after diagnosis of DVT |
| Vein Specific Quality of Life | Measured using The Venous Insufficiency Epidemiological and Economic Study (VEINES) QOL survey. Scores range from 0-100 with higher scores indicating better quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-thrombotic syndrome | Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms. | 3 and 12 months after diagnosis of DVT |
| Vein Specific Quality of Life | Measured using The Venous Insufficiency Epidemiological and Economic Study (VEINES) QOL survey. Scores range from 0-100 with higher scores indicating better quality of life. |
Inclusion Criteria:
Exclusion Criteria
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Patients with acute, proximal DVT initiating anticoagulation
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| Name | Affiliation | Role |
|---|---|---|
| Damon Houghton, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months after diagnosis of DVT |
| 3 and 12 months after diagnosis of DVT |
| Thrombus Resolution | Measured quantitatively by outflow parameters on air plethysmography with expelled volume measured at 1 second x 60 sec (ml/100ml/minute), expelled volume after 4 seconds, and maximum volume expelled. | 3 Months after diagnosis of DVT. |
| D014689 |
| Venous Insufficiency |