NCT02672618

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

January 26, 2016

Last Update Submit

February 2, 2016

Conditions

Keywords

heart failureinfrared thermal imaging

Outcome Measures

Primary Outcomes (1)

  • Surface temperature (℃)of face and hand measured by Infrared (IR) camera

    up to 12 months

Secondary Outcomes (4)

  • LVEF(left ventricular ejection fraction)

    up to 12 months

  • proBNP(pro Brain Natriuretic Peptide)

    up to 12 months

  • catecholamine levels

    up to 12 months

  • Entropy of thermal image

    up to 12 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The 2nd Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

3Rd People'S Hospital of Chengdu

Chengdu, Sichuan, China

NOT YET RECRUITING

The First Affiliated Hospital of Sichuan Medical University:

Luzhou, Sichuan, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University:

Chongqing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • hang jing

    Chongqing Medical University

    STUDY DIRECTOR

Central Study Contacts

huang jing

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor,vice director

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 3, 2016

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

February 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations