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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02672618
Other study ID # JHuang
Secondary ID
Status Recruiting
Phase N/A
First received January 26, 2016
Last updated February 2, 2016
Start date November 2015
Est. completion date June 2017

Study information

Verified date February 2016
Source The Second Affiliated Hospital of Chongqing Medical University
Contact huang jing
Email huangjing@cqmu.edu.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore manifestations of Heart Failure Using Infrared Thermal Imaging Technology.


Description:

Temperature is a vital and useful indicator for various diseases.Infrared thermal imaging (IRTI) allows the temperature representation of the body surface by thermal distribution, where it depends on the complex relationships defining the heat exchange processes between skin tissue, inner tissue, local vasculature, and metabolic activity.

The decrease in cardiac output in heart failure activate a series of compensatory adaption that are intended to maintain cardiovascular homeostasis. One of most important adaptation is activation of sympathetic nervous system, which could cause peripheral cutaneous vasoconstriction and decrease the skim temperature. Hence, the skim temperature of heart failure would be lower than health people,but which could not discovery by eye. The investigators hypothesize that IRTI could evaluate heart failure by the imaging of temperature distribution in the face on early stages.The aim of this study is to determine the effectiveness of infrared thermal imaging in evaluating heart failure.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

1. Willing to participate in the trial and sign the informed consent form

2. Aged: 18-85 years

3. Was diagnosed as heart failure

4. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (face)

5. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases

Exclusion Criteria:

1. Fever causes by any reasons, temperature higher than 37.4?

2. Infection

3. Renal failure

4. Cerebrovascular diseases

5. Moderate anemia or more

6. Not willing to participate in clinical trials

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
China 3Rd People'S Hospital of Chengdu Chengdu Sichuan
China The 2nd Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China The First Affiliated Hospital of Chongqing Medical University: Chongqing
China The First Affiliated Hospital of Sichuan Medical University: Luzhou Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Jing Huang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surface temperature (?)of face and hand measured by Infrared (IR) camera up to 12 months No
Secondary LVEF(left ventricular ejection fraction) up to 12 months No
Secondary proBNP(pro Brain Natriuretic Peptide) up to 12 months No
Secondary catecholamine levels up to 12 months No
Secondary Entropy of thermal image Entropy of thermal image: show chaos degree of skim temperature distribution. up to 12 months No
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