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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672618
Recruitment Status : Unknown
Verified February 2016 by Jing Huang, The Second Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Jing Huang, The Second Affiliated Hospital of Chongqing Medical University

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

Condition or disease
Heart Failure,Congestive

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Cross-Sectional
Official Title: Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
Study Start Date : November 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
chronic heart failure
18-85years old,having symptoms of heart failure,New York Heart Association(NYHA) class II or above American College of Cardiology/American Heart Association(ACC/AHA) class B, C, including hypertensive heart disease, rheumatic heart disease, ischemic cardiomyopathy and idiopathic cardiomyopathy
normalCardiac function
18-85years old,no symptoms of heart failure,NYHA class I or above ACC/AHA class A, including controled hypertension,stability coronary heart disease and rheumatic heart disease
healthy volunteers
18-85years old,Without basic cardiovascular diseases



Primary Outcome Measures :
  1. Surface temperature (℃)of face and hand measured by Infrared (IR) camera [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. LVEF(left ventricular ejection fraction) [ Time Frame: up to 12 months ]
  2. proBNP(pro Brain Natriuretic Peptide) [ Time Frame: up to 12 months ]
  3. catecholamine levels [ Time Frame: up to 12 months ]
  4. Entropy of thermal image [ Time Frame: up to 12 months ]
    Entropy of thermal image: show chaos degree of skim temperature distribution.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672618


Contacts
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Contact: huang jing huangjing@cqmu.edu.cn

Locations
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China, Chongqing
The 2nd Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400010
Contact: Jing Huang, MD    0086-13508312022    huangjing@cqmu.edu.cn   
Principal Investigator: Jing Huang, MD         
China, Sichuan
3Rd People'S Hospital of Chengdu Not yet recruiting
Chengdu, Sichuan, China
Contact: Wang chunbin         
The First Affiliated Hospital of Sichuan Medical University: Not yet recruiting
Luzhou, Sichuan, China
Contact: Jiang feng         
China
The First Affiliated Hospital of Chongqing Medical University: Not yet recruiting
Chongqing, China
Contact: Guo rui         
Sponsors and Collaborators
Jing Huang
Investigators
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Study Director: hang jing Chongqing Medical University
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Responsible Party: Jing Huang, professor,vice director, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02672618    
Other Study ID Numbers: JHuang
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Jing Huang, The Second Affiliated Hospital of Chongqing Medical University:
heart failure
infrared thermal imaging
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases