Clinical trial NCT02672618: Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
Official title: Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure，Congestive
Keywords: heart failure
infrared thermal imaging
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients included in this study had been definitively diagnosed as having with Echocardiography. The healthy volunteer group matched the HF group in number, age, and gender.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surface temperature (℃）of face and hand measured by Infrared (IR) camera
timeFrame: up to 12 months
Secondary outcomes:
measure: LVEF（left ventricular ejection fraction）
timeFrame: up to 12 months
measure: proBNP(pro Brain Natriuretic Peptide)
timeFrame: up to 12 months
measure: catecholamine levels
timeFrame: up to 12 months
measure: Entropy of thermal image
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The 2nd Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chengdu
country: China
facility: 3Rd People'S Hospital of Chengdu
state: Sichuan
city: Luzhou
country: China
facility: The First Affiliated Hospital of Sichuan Medical University:
state: Sichuan
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University:
Study officials:
affiliation: Chongqing Medical University
name: hang jing
role: STUDY_DIRECTOR
References: