Ultrasound Elasticity Imaging of Venous Thrombi

NCT00726947 | Completed Early Phase 1

• 2 other identifiers: HUM 0040239NIH ROI HL 78656-01A1
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if the investigators can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

• To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots

  approximately one year

Secondary Outcomes (1)

• Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS)

  first year following diagnosis of acute DVT

Study Arms (2)

1

EXPERIMENTAL

Ultrasound imaging of Acute DVT (deep vein thrombosis)

Procedure: Ultrasound

2

EXPERIMENTAL

Ultrasound imaging of Chronic DVT (deep vein thrombosis)

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

Ultrasound imaging of Acute DVT

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT.
• Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks.
• Patients under the age of 18 who give assent (permission) and whose parents give consent.
• Adult patients who give consent.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Jonathan Rubin, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: December 1, 2002
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2011
• Last Updated: May 24, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)