Heart DiseasesNCT02168049
Heart and Lung Function Monitoring System
A study testing Integrated CardioRespiratory System, Transthoracic Echocardiography (TTE) and Electrocardiography in people with Heart Diseases and Lung Diseases, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Lung Diseases
- What is being tested?
- Integrated CardioRespiratory System, Transthoracic Echocardiography (TTE) and Electrocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult's ≥ 18 years old
Who cannot join
- Wounds, surgical incisions at the site of sensor placement
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: Heart and Lung Function Monitoring System Evaluation
The investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.
Read the detailed description
The purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.
- Conditions
- Heart Diseases, Lung Diseases
- Being tested
- Integrated CardioRespiratory System, Transthoracic Echocardiography (TTE), Electrocardiography
- Keywords
- cardiac, respiratory, monitoring
- Medical subject headings
- Heart Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated CardioRespiratory SystemDevice
Participants will be asked to wear a non-invasive band on their upper abdomen while laying down. This band includes acoustic sensors. A remote monitoring device will continuously monitor and record heart rate and lung volumes and function.
Transthoracic Echocardiography (TTE)Device
Participants will undergo a TTE examination. During the TTE, a technician obtains views of the heart by moving a small instrument called a transducer to different locations on the chest or abdominal wall.
ElectrocardiographyDevice
Also called ECG
Participants will also have ECG monitoring as part of the TTE exam, which records the electrical activity of the heart using electrodes placed on the body.
| Study group | Role | What they receive |
|---|---|---|
| Heart and Lung Function Monitioring | Experimental | Not described Receives: Device: Integrated CardioRespiratory System; Device: Transthoracic Echocardiography (TTE); Device: Electrocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic heart sound electronic data
Heart and lung function monitoring
Measured: 60 minutes during system trial
Secondary outcomes (1)
Standard echocardiography parameters
Transthoracic Echocardiography (TTE)
Measured: 60 minutes during examination simultaneous with system trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Howard-Quijano, M.D., M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168049
- Sponsor's protocol ID
- ICR14-000670
- Status last verified
- Mar 2024
- First submitted
- 11 Jun 2014
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart and Lung Function Monitoring System Evaluation
- ClinicalTrials.gov ID
- NCT02168049
- Acronym / sponsor ID
- ICR14-000670
- Conditions
- Heart Diseases, Lung Diseases
- Keywords
- cardiac, respiratory, monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 Jun 2014 (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 investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.
Detailed description
The purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart and Lung Function Monitioring | Experimental | Device: Integrated CardioRespiratory System, Device: Transthoracic Echocardiography (TTE), Device: Electrocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult's ≥ 18 years old
Key exclusion criteria (1 listed)
- Wounds, surgical incisions at the site of sensor placement
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 |
|---|---|---|
| Integrated CardioRespiratory SystemParticipants will be asked to wear a non-invasive band on their upper abdomen while laying down. This band includes acoustic sensors. A remote monitoring device will continuously monitor and record heart rate and lung volumes and function. | Device | Heart and Lung Function Monitioring |
| Transthoracic Echocardiography (TTE)Participants will undergo a TTE examination. During the TTE, a technician obtains views of the heart by moving a small instrument called a transducer to different locations on the chest or abdominal wall. | Device | Heart and Lung Function Monitioring |
| ElectrocardiographyAlso: ECGParticipants will also have ECG monitoring as part of the TTE exam, which records the electrical activity of the heart using electrodes placed on the body. | Device | Heart and Lung Function Monitioring |
Primary outcome
Acoustic heart sound electronic data
Time frame: 60 minutes during system trial
Heart and lung function monitoring
1 secondary outcome
Standard echocardiography parameters
Time frame: 60 minutes during examination simultaneous with system trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Kimberly Howard-Quijano, M.D., M.S. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated CardioRespiratory System, Transthoracic Echocardiography (TTE) and Electrocardiography in people with Heart Diseases and Lung Diseases, run by University of California, Los Angeles at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic heart sound electronic data (time frame: 60 minutes during system trial). 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 6 Mar 2024.