The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism

The purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).

Study Overview

• Status: Completed
• Conditions: Deep Venous Thrombosis

• Study Type: Observational
• Enrollment (Actual): 128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

DVT patients included in this study had been definitively diagnosed as having DVT with CPUS and/or angiography. Included non-DVT volunteers were confirmed to be without DVT with CPUS. The healthy volunteer group matched the DVT group in number, age, and gender.

Description

Inclusion Criteria:

1. Willing to participate in the trial and sign the informed consent form,
2. Aged: 18-75 years. They had been definitively diagnosed with venous thromboembolism,
3. The bed-rest immobilization time should be more than 72 hours,
4. Planing to gynecology operation,
5. The D dimer should be more than500 g • L-1,
6. There is no obvious symptoms of systemic infection two weeks before the test,
7. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (chest and lower limbs),
8. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases.

Exclusion Criteria:

1. Patients can not be good partners,
2. Doctors believe that there is any inappropriate situations.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Using the Infrared Thermal Imaging to detecting Venous Thromboembolism	① Different levels of pseudocode (white, red, pink, yellow, green, blue, black) representing related IRTI that corresponds to a color scale bar of low to high temperatures, so we can know disease's position, extent and severity by comparing with the difference of color distribution and shape in the thermal imaging. ②The intensity of thermal distribution is higher than normals (great than or equal 0.5 Celsius degree is unnoraml), the symmetry of thermal range is relatively increased (pixels over 0.5 ~ 1.0-fold), the difference of spatial distribution of the thermal field and the difference of statistically analyze are related to the disease.	up to 24 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 15, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: deep venous thrombosis; infrared thermal imaging
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: GIRD