Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology

Heart Failure,Congestive Clinical Trial

Official title:

Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672618
• Other study ID #: JHuang
• 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

• Heart Failure
• Heart Failure,Congestive

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