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Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04597138
Collaborator
(none)
200
Enrollment
1
Location
22.9
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Relationship Between Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome
    Actual Study Start Date :
    Nov 2, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Thrombus Resolution [3 Months after diagnosis of DVT.]

      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.

    Secondary Outcome Measures

    1. Post-thrombotic syndrome [6 months after diagnosis of DVT]

      Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.

    2. Vein Specific Quality of Life [6 months after diagnosis of DVT]

      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.

    Other Outcome Measures

    1. Post-thrombotic syndrome [3 and 12 months after diagnosis of DVT]

      Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.

    2. Vein Specific Quality of Life [3 and 12 months after diagnosis of DVT]

      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.

    3. Thrombus Resolution [3 Months after diagnosis of DVT.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours

    • ≥18 Years Old

    Exclusion Criteria

    • prior episode of DVT

    • contraindication to standard therapeutic anticoagulation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Damon Houghton, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Damon E. Houghton, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04597138
    Other Study ID Numbers:
    • 20-002573
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Damon E. Houghton, Principal Investigator, Mayo Clinic
    Thrombus Resolution
    Post-Thrombotic Syndrome
    Additional relevant MeSH terms:
    Thrombosis
    Venous Thrombosis
    Postthrombotic Syndrome
    Postphlebitic Syndrome

    Study Results

    No Results Posted as of Nov 23, 2021