End-stage Renal DiseaseNCT03661229
Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device
A study testing CVInsight Monitoring in people with End-stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients on hemodialysis treatment experience increased levels of cardiovascular disease. In this study, investigators will be detecting hemodialysis induced circulatory stress using the CVInsight Patient Monitoring \& Informatics System - InteloMed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- CVInsight Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2018to 8 Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving conventional thrice weekly maintenance HD
- Age ≥18 years
- Able to provide informed consent
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Patients on hemodialysis treatment experience increased levels of cardiovascular disease. In this study, investigators will be detecting hemodialysis induced circulatory stress using the CVInsight Patient Monitoring \& Informatics System - InteloMed. This system consists of the CVInsight non-contact device and the CVInsight contact device that measures a patient's response to dialysis by looking at many physiological parameters such as heart rate, heart rate variability, respiratory rate, and how much oxygen the blood is carrying. Investigators would like to validate the mobile CVInsight non-contact device to the currently used standard CVInsight contact device to provide healthcare providers with a better understanding of its role in early detection of cardiovascular stress induced by hemodialysis.
Read the detailed description
This observational validation trial involves patients from the prevalent dialysis population in London, Ontario. Investigators intend to validate the mobile CVInsight non-contact device to the standard contact version of this device for assessing hemodialysis induced circulatory stress. The CVInsight Patient Monitoring \& Informatics System records a patient's pulse waveform to determine a patient's response to dialysis and alerts to several physiologic changes including pulse strength, pulse rate, pulse irregularity, oxygen saturation, and oxygen saturation variability. The CVInsight contact and non-contact devices will be used for two study visits. The first study visit will be on the patient's first dialysis session of the week (after the weekend - 72 hour inter-dialytic period) and the second study visit will be during the patient's second dialysis session of the week (mid week - 48 hour inter-dialytic period). This will allow investigators to see if there is a difference between these two intervals of time. The investigators will also be using other gold standard methods of validating components of this device including myocardial stunning using the GE Healthcare Vivid q cardiovascular ultrasound system. The echocardiographic ultrasound machine and finometer will be used for two study visits to take place during the patients' regularly scheduled dialysis sessions. The first echocardiogram will be done prior to the initiation of dialysis and the second at peak dialysis stress, which is 15 minutes before the end of the hemodialysis treatment. In addition, the finometer will be used continuously throughout hemodialysis.Validating the mobile CVInsight non-contact device to the CVInsight contact device will allow investigators to observe the degree to which these devices are able to detect hemodialysis induced circulatory stress, which will enable the healthcare provider to detect injury early enough to intervene prior to its occurrence. This is important because hemodialysis and the accompanying stress it induces increases mortality significantly in this population of patients.
This study is investigator initiated and the study will continue until the investigators reach our target sample size.
Each patient will have two study visits. Patients on a Monday, Wednesday, and Friday schedule will have study visits on Monday and Wednesday of the same week and patients on a Tuesday, Thursday, and Saturday schedule will have study visits on Tuesday and Thursday of the same week.
- Conditions
- End-stage Renal Disease
- Being tested
- CVInsight Monitoring
- Keywords
- CVInsight, Hemodialysis, Cardiovascular stress
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVInsight MonitoringDevice
All participants (n=50) will receive CVInsight non-contact device and CVInsight contact device application during two of their regularly scheduled dialysis sessions.
| Study group | Role | What they receive |
|---|---|---|
| CVInsight Monitoring | Experimental | Single group arm: All participants receive the same intervention/treatment CVInsight non-contact device and CVInsight contact device application. Receives: Device: CVInsight Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends
Validation of the mobile CVInsight with pulse rate from the CVInsight contact device
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording pulse strength
Validation of the mobile CVInsight with pulse strength (derived from a photoelectric plethysmograph waveform) from the CVInsight contact device
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording pulse irregularity
Validation of the mobile CVInsight with pulse irregularity (derived from the pulse wave signal) from the CVInsight contact device
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation
Validation of the mobile CVInsight with the percentage of oxygen carried in blood from the CVInsight contact device
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation variability
Validation of the mobile CVInsight with the oxygen saturation variability (derived from the oximeter signal) from the CVInsight contact device
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Secondary outcomes (3)
Early detection of hemodialysis-induced circulatory stress using the CVInsight System
The secondary outcome will be assessment of the contact and non-contact CVInsight devices on hemodialysis induced circulatory stress
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Early detection of hemodialysis-induced circulatory stress using the finometer
The secondary outcome will be assessment of the finometer on hemodialysis induced circulatory stress
Measured: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Early detection of hemodialysis-induced circulatory stress using echocardiography
The secondary outcome will be assessment of echocardiography on hemodialysis induced circulatory stress
Measured: Before the dialysis session and 15 minutes prior to the end of the dialysis session for two separate visits within the same week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start21 Oct 2018
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Why it stopped: Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 50 patients will be assessed using the CVInsight Monitoring System. Patients will undergo two consecutive hemodialysis (HD) treatments where they will be monitored with the contact and non-contact devices throughout their HD session. The first visit will be on their first HD session of the week (after the weekend - 72 hour inter-dialytic period) and the second visit will be during the patient's second HD session of the week (mid-week - 48 hour inter-dialytic period). This will allow us to see if there is a difference between these two intervals of time. Twenty of these patients will have additional monitoring including movement of left ventricle using echocardiography and continuous blood pressure monitoring using a finometer. The first echocardiogram will be done prior to the initiation of HD and the second at peak HD stress, which is 15 minutes before the end of the HD treatment. 20/50 patients will be chosen according to patient treatment schedule and staff schedule.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Intelomed, Inc.
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher McIntyre, MBBS DM, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661229
- Sponsor's protocol ID
- 112553
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2018
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device
- ClinicalTrials.gov ID
- NCT03661229
- Acronym / sponsor ID
- 112553
- Conditions
- End-stage Renal Disease
- Keywords
- CVInsight, Hemodialysis, Cardiovascular stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Intelomed, Inc.
- Study start
- 21 Oct 2018 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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.
Patients on hemodialysis treatment experience increased levels of cardiovascular disease. In this study, investigators will be detecting hemodialysis induced circulatory stress using the CVInsight Patient Monitoring \& Informatics System - InteloMed. This system consists of the CVInsight non-contact device and the CVInsight contact device that measures a patient's response to dialysis by looking at many physiological parameters such as heart rate, heart rate variability, respiratory rate, and how much oxygen the blood is carrying. Investigators would like to validate the mobile CVInsight non-contact device to the currently used standard CVInsight contact device to provide healthcare providers with a better understanding of its role in early detection of cardiovascular stress induced by hemodialysis.
Detailed description
This observational validation trial involves patients from the prevalent dialysis population in London, Ontario. Investigators intend to validate the mobile CVInsight non-contact device to the standard contact version of this device for assessing hemodialysis induced circulatory stress. The CVInsight Patient Monitoring \& Informatics System records a patient's pulse waveform to determine a patient's response to dialysis and alerts to several physiologic changes including pulse strength, pulse rate, pulse irregularity, oxygen saturation, and oxygen saturation variability. The CVInsight contact and non-contact devices will be used for two study visits. The first study visit will be on the patient's first dialysis session of the week (after the weekend - 72 hour inter-dialytic period) and the second study visit will be during the patient's second dialysis session of the week (mid week - 48 hour inter-dialytic period). This will allow investigators to see if there is a difference between these two intervals of time. The investigators will also be using other gold standard methods of validating components of this device including myocardial stunning using the GE Healthcare Vivid q cardiovascular ultrasound system. The echocardiographic ultrasound machine and finometer will be used for two study visits to take place during the patients' regularly scheduled dialysis sessions. The first echocardiogram will be done prior to the initiation of dialysis and the second at peak dialysis stress, which is 15 minutes before the end of the hemodialysis treatment. In addition, the finometer will be used continuously throughout hemodialysis.Validating the mobile CVInsight non-contact device to the CVInsight contact device will allow investigators to observe the degree to which these devices are able to detect hemodialysis induced circulatory stress, which will enable the healthcare provider to detect injury early enough to intervene prior to its occurrence. This is important because hemodialysis and the accompanying stress it induces increases mortality significantly in this population of patients.
This study is investigator initiated and the study will continue until the investigators reach our target sample size.
Each patient will have two study visits. Patients on a Monday, Wednesday, and Friday schedule will have study visits on Monday and Wednesday of the same week and patients on a Tuesday, Thursday, and Saturday schedule will have study visits on Tuesday and Thursday of the same week.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 50 patients will be assessed using the CVInsight Monitoring System. Patients will undergo two consecutive hemodialysis (HD) treatments where they will be monitored with the contact and non-contact devices throughout their HD session. The first visit will be on their first HD session of the week (after the weekend - 72 hour inter-dialytic period) and the second visit will be during the patient's second HD session of the week (mid-week - 48 hour inter-dialytic period). This will allow us to see if there is a difference between these two intervals of time. Twenty of these patients will have additional monitoring including movement of left ventricle using echocardiography and continuous blood pressure monitoring using a finometer. The first echocardiogram will be done prior to the initiation of HD and the second at peak HD stress, which is 15 minutes before the end of the HD treatment. 20/50 patients will be chosen according to patient treatment schedule and staff schedule.
| Arm | Type | Receives |
|---|---|---|
| CVInsight Monitoring | Experimental | Device: CVInsight MonitoringSingle group arm: All participants receive the same intervention/treatment CVInsight non-contact device and CVInsight contact device application. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving conventional thrice weekly maintenance HD
- Age ≥18 years
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| CVInsight MonitoringAll participants (n=50) will receive CVInsight non-contact device and CVInsight contact device application during two of their regularly scheduled dialysis sessions. | Device | CVInsight Monitoring |
Primary outcome
Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with pulse rate from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording pulse strength
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with pulse strength (derived from a photoelectric plethysmograph waveform) from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording pulse irregularity
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with pulse irregularity (derived from the pulse wave signal) from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with the percentage of oxygen carried in blood from the CVInsight contact device
Mobile CVInsight validation against the CVInsight contact device by recording oxygen saturation variability
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Validation of the mobile CVInsight with the oxygen saturation variability (derived from the oximeter signal) from the CVInsight contact device
3 secondary outcomes
Early detection of hemodialysis-induced circulatory stress using the CVInsight System
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Early detection of hemodialysis-induced circulatory stress using the finometer
Time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.
Early detection of hemodialysis-induced circulatory stress using echocardiography
Time frame: Before the dialysis session and 15 minutes prior to the end of the dialysis session for two separate visits within the same week.
Results and safety
The study was stopped early (reason given: Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
Christopher McIntyre, MBBS DM principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVInsight Monitoring in people with End-stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 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: stopped early, as of the sponsor's last update on 19 Aug 2021. 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 Canada. 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 was stopped early (reason given: Inability to demonstrate efficacy. The reason for this is that we were unable to get the necessary information from our population of dialysis patient using the mCVI™ non-contact facial tracking cell phone app.). Results are not available in the source record.
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?
Mobile CVInsight validation against the CVInsight contact device by recording pulse rate trends (time frame: Through dialysis session, an average of 4 hours for two separate visits within the same week.). The study lists 5 primary outcomes in all. 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 19 Aug 2021.