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

Sponsor
Jing Huang (Other)
Overall Status
Unknown status
CT.gov ID
NCT02672618
Collaborator
(none)
200
Enrollment
4
Locations
19
Duration (Months)
50
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Nov 1, 2015
    Anticipated Primary Completion Date :
    Jan 1, 2017
    Anticipated Study Completion Date :
    Jun 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Surface temperature (℃）of face and hand measured by Infrared (IR) camera [up to 12 months]

    Secondary Outcome Measures

    1. LVEF（left ventricular ejection fraction） [up to 12 months]

    2. proBNP(pro Brain Natriuretic Peptide) [up to 12 months]

    3. catecholamine levels [up to 12 months]

    4. Entropy of thermal image [up to 12 months]

      Entropy of thermal image: show chaos degree of skim temperature distribution.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The 2nd Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400010
    2 3Rd People'S Hospital of Chengdu Chengdu Sichuan China
    3 The First Affiliated Hospital of Sichuan Medical University: Luzhou Sichuan China
    4 The First Affiliated Hospital of Chongqing Medical University: Chongqing China

    Sponsors and Collaborators

    • Jing Huang

    Investigators

    • Study Director: hang jing, Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Feb 3, 2016
    Last Update Posted:
    Feb 3, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Jing Huang, professor，vice director, The Second Affiliated Hospital of Chongqing Medical University
    heart failure
    infrared thermal imaging
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 3, 2016