Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-28 @ 7:10 AM
Study NCT ID:
NCT02672618
Status:
UNKNOWN
Last Update Posted:
2016-02-03
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface temperature (℃）of face and hand measured by Infrared (IR) camera', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'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', 'description': 'Entropy of thermal image: show chaos degree of skim temperature distribution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heart failure', 'infrared thermal imaging'], 'conditions': ['Heart Failure，Congestive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore manifestations of Heart Failure Using Infrared Thermal Imaging Technology.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to participate in the trial and sign the informed consent form\n2. Aged: 18-85 years\n3. Was diagnosed as heart failure\n4. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (face)\n5. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases\n\nExclusion Criteria:\n\n1. Fever causes by any reasons, temperature higher than 37.4℃\n2. Infection\n3. Renal failure\n4. Cerebrovascular diseases\n5. Moderate anemia or more\n6. Not willing to participate in clinical trials'}, 'identificationModule': {'nctId': 'NCT02672618', 'briefTitle': 'Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Clinical Research to Explore Manifestations of Heart Failure Using Infrared Thermal Imaging Technology', 'orgStudyIdInfo': {'id': 'JHuang'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic heart failure', 'description': '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'}, {'label': 'normalCardiac function', 'description': '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'}, {'label': 'healthy volunteers', 'description': '18-85years old,Without basic cardiovascular diseases'}], 'interventions': [{'type': 'OTHER', 'description': '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）.', 'armGroupLabels': ['chronic heart failure', 'healthy volunteers', 'normalCardiac function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Huang, MD', 'role': 'CONTACT', 'email': 'huangjing@cqmu.edu.cn', 'phone': '0086-13508312022'}, {'name': 'Jing Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 2nd Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang chunbin', 'role': 'CONTACT'}], 'facility': "3Rd People'S Hospital of Chengdu", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Luzhou', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang feng', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Sichuan Medical University:', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'city': 'Chongqing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo rui', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University:', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'huang jing', 'role': 'CONTACT', 'email': 'huangjing@cqmu.edu.cn'}], 'overallOfficials': [{'name': 'hang jing', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing Huang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor，vice director', 'investigatorFullName': 'Jing Huang', 'investigatorAffiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}}}}