Ultrasound Elasticity Imaging of Venous Thrombi - Full Text View

Sponsors and Collaborators:	University of Michigan National Institutes of Health (NIH)
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00726947

Purpose

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.

Condition	Intervention	Phase
Thrombosis	Procedure: Ultrasound	Phase 0

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Aging Venous Thrombi With Ultrasound Elasticity Imaging

Further study details as provided by University of Michigan:

Primary Outcome Measures:

To determine if ultrasound imaging will aid in the diagnosis and classification of venous blood clots [ Designated as safety issue: No ]

Secondary Outcome Measures:

Follow-up with subjects who have been diagnosed with Acute DVT to see if they develop post-thrombotic syndrome (PTS) [ Time Frame: first year following diagnosis of acute DVT ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	December 2002

Arms	Assigned Interventions
1: Experimental Ultrasound imaging of Acute DVT	Procedure: Ultrasound Ultrasound imaging of Acute DVT
2: Experimental Ultrasound imaging of Chronic DVT	Procedure: Ultrasound Ultrasound imaging of Chronic DVT

Detailed Description:

Deep vein thrombosis (DVT) is a blood clot and is a common illness that can result in pain and death if not recognized and treated well. Death can occur when the venous clots break off and form pulmonary emboli (PE), which can block the arteries of the lungs. DVT and PE most often complicate the course of sick patients but may also affect healthy persons. DVT can also be a chronic disease. In those instances in which DVT and PE develop, in addition to the death risk, hospitalization is drawn out and healthcare costs are increased. Therefore, the purpose of this study is to see if we can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726947

Locations

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Jonathan Rubin, M.D.

University of Michigan Health System

More Information

Responsible Party:	University of Michigan Health System ( Jonathan Rubin, M.D. )
Study ID Numbers:	2001-0143, NIH ROI HL 78656-01A1
Study First Received:	July 29, 2008
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00726947
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009