Heart Failure，CongestiveNCT02672618
Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
An observational study of Heart Failure，Congestive, run by Jing Huang at 4 sites in China.
Trial summary
The purpose of this study is to explore manifestations of Heart Failure Using Infrared Thermal Imaging Technology. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure，Congestive
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- Nov 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Willing to participate in the trial and sign the informed consent form
- Aged: 18-85 years
- Was diagnosed as heart failure
- There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (face)
- There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases
Who cannot join
- Fever causes by any reasons, temperature higher than 37.4℃
- Infection
- Renal failure
- Cerebrovascular diseases
- Moderate anemia or more
- Not willing to participate in clinical trials
Trial locations and contacts
4 sites in 1 country.
huang jing contact
China4 sites, 4 recruiting
- Not yet recruiting
3Rd People'S Hospital of Chengdu
Chengdu, Sichuan
Wang chunbin
- Recruiting
The 2nd Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Jing Huang, MD, 0086-13508312022, huangjing@cqmu.edu.cn
Jing Huang, MD
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University:
Chongqing
Guo rui
- Not yet recruiting
The First Affiliated Hospital of Sichuan Medical University:
Luzhou, Sichuan
Jiang feng
About this study
The purpose of this study is to explore manifestations of Heart Failure Using Infrared Thermal Imaging Technology.
Read the 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.
- Conditions
- Heart Failure，Congestive
- Keywords
- heart failure, infrared thermal imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
The IRS system is capable of precisely measuring and storing real-time thermal images with a resolution of 320×240 pixels (IRS S6md Shanghai,China). The camera has Focal Plane Array (FPA), Uncooled microbolometer detector, with a thermal sensitivity of 0.05 ℃ at 20℃ to 30℃. The thermal images were captured at a distance of one meter from the various body regions namely face and the images were analyzed by thermal software（version 1.0）.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface temperature (℃）of face and hand measured by Infrared (IR) camera
Measured: up to 12 months
Secondary outcomes (4)
LVEF（left ventricular ejection fraction）
Measured: up to 12 months
proBNP(pro Brain Natriuretic Peptide)
Measured: up to 12 months
catecholamine levels
Measured: up to 12 months
Entropy of thermal image
Entropy of thermal image: show chaos degree of skim temperature distribution.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Huang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- hang jing, Study director, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672618
- Sponsor's protocol ID
- JHuang
- Status last verified
- Feb 2016
- First submitted
- 26 Jan 2016
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
- ClinicalTrials.gov ID
- NCT02672618
- Acronym / sponsor ID
- JHuang
- Conditions
- Heart Failure，Congestive
- Keywords
- heart failure, infrared thermal imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jing HuangUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Willing to participate in the trial and sign the informed consent form
- Aged: 18-85 years
- Was diagnosed as heart failure
- There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (face)
- There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases
Key exclusion criteria (6 listed)
- Fever causes by any reasons, temperature higher than 37.4℃
- Infection
- Renal failure
- Cerebrovascular diseases
- Moderate anemia or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The IRS system is capable of precisely measuring and storing real-time thermal images with a resolution of 320×240 pixels (IRS S6md Shanghai,China). The camera has Focal Plane Array (FPA), Uncooled microbolometer detector, with a thermal sensitivity of 0.05 ℃ at 20℃ to 30℃. The thermal images were captured at a distance of one meter from the various body regions namely face and the images were analyzed by thermal software（version 1.0）. | Other | chronic heart failure, healthy volunteers, normalCardiac function |
Primary outcome
Surface temperature (℃）of face and hand measured by Infrared (IR) camera
Time frame: up to 12 months
4 secondary outcomes
LVEF（left ventricular ejection fraction）
Time frame: up to 12 months
proBNP(pro Brain Natriuretic Peptide)
Time frame: up to 12 months
catecholamine levels
Time frame: up to 12 months
Entropy of thermal image
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Individual participant dataSharing planned: Yes
Related trials for Heart Failure，Congestive
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
huang jing contact
hang jing study director
Chongqing Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure，Congestive, run by Jing Huang at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huang jing (huangjing@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface temperature (℃）of face and hand measured by Infrared (IR) camera (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.