Patients Referred to St. Michael's Hospital Echocardiography LabNCT01623986
Correlation of Measurements From Mespere Venus 1000 System & Echocardiography to Estimate Right Atrial Pressure
An observational study of Patients Referred to St. Michael's Hospital Echocardiography Lab, run by Mespere Lifesciences Inc. at 1 site in Canada.
Trial summary
The purpose of this clinical study is to investigate if central venous pressure (CVP) measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP) when estimating right ventricular systolic pressure (RVSP) in echocardiography labs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Referred to St. Michael's Hospital Echocardiography Lab
- What is being tested?
- Mespere Venus 1000 System and Echocardiography machine
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients referred to St. Michael's Hospital echocardiography lab
Who may be able to join
- Age 18 and older
- Patient referred to St. Michael's Hospital Echocardiography Lab
- Signed written and informed consent
Who cannot join
- Lack of patient consent
- Presence of known AV dialysis fistula
- Allergy to adhesive tape from Mespere Venus 1000 system
- Known central vein stenosis
- Unable to identify right external jugular vein
- Ongoing photodynamic therapy
- Assisted ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical Correlation of a Noninvasive Estimation of Central Venous Pressure From the Mespere Venus 1000 System and the Inferior Vena Cava From Echocardiography, to Estimate Right Atrial Pressure
The purpose of this clinical study is to investigate if central venous pressure (CVP) measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP) when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.
Read the detailed description
The non-invasive assessment of the pressure on the right side of your heart using an imaging machine called a Doppler echocardiography machine (also known as an ECHO machine) is a widely accepted technique and is used as a screening tool for pulmonary hypertension and heart failure. The pressure on this side of your heart reflects the pressure of the blood in your veins returning to your heart and the effectiveness of your heart to pump that blood to your lungs. The accuracy of this technique depends on making an accurate estimate of the pressure in the upper chamber (atrium) of the right side of your heart, known as your right atrial pressure (RAP). Right atrium pressure can be measured non-invasively by imaging of your heart using an echocardiography (aka ECHO) machine. But the technique depends on the skills of the sonographer (the person who operates the ECHO machine) and can take considerable time to complete.
In view of this limitation, a non-invasive technique that could be used to make the RAP measurements may be more reliable and/or faster than the current technique.
Mespere Lifesciences Inc. has developed a new non-invasive device that is expected to allow for a simple, rapid and reliable measurement of RAP. The device consists of a set of light sensors on a patch that is placed onto the surface of the patient's right side of the neck.
- Being tested
- Mespere Venus 1000 System, Echocardiography machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere Venus 1000 SystemDevice
An adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with right atrial pressure values obtained by echocardiography(standard clinical practice)
Echocardiography machineDevice
Also called ECHO machine
Use of ultrasound to estimate right atrial pressure from analyzing inferior vena cava (IVC).
| Study group | Role | What they receive |
|---|---|---|
| St. Michael's Hospital Patients | Patients who are referred to the St. Michael's Hospital echocardiography (ECHO) lab. Receives: Device: Mespere Venus 1000 System; Device: Echocardiography machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right atrial pressure (RAP)
To determine if the RAP from the non-invasive Mespere Venus 1000 System correlates with the RAP from an echocardiography (ECHO) machine
Measured: 0-1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Referred to St. Michael's Hospital Echocardiography LabStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chi-Ming Chow, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623986
- Sponsor's protocol ID
- MLS STP-9000010
- Status last verified
- Aug 2014
- First submitted
- 18 Jun 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Correlation of a Noninvasive Estimation of Central Venous Pressure From the Mespere Venus 1000 System and the Inferior Vena Cava From Echocardiography, to Estimate Right Atrial Pressure
- ClinicalTrials.gov ID
- NCT01623986
- Acronym / sponsor ID
- MLS STP-9000010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Jun 2012 (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 clinical study is to investigate if central venous pressure (CVP) measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP) when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.
Detailed description
The non-invasive assessment of the pressure on the right side of your heart using an imaging machine called a Doppler echocardiography machine (also known as an ECHO machine) is a widely accepted technique and is used as a screening tool for pulmonary hypertension and heart failure. The pressure on this side of your heart reflects the pressure of the blood in your veins returning to your heart and the effectiveness of your heart to pump that blood to your lungs. The accuracy of this technique depends on making an accurate estimate of the pressure in the upper chamber (atrium) of the right side of your heart, known as your right atrial pressure (RAP). Right atrium pressure can be measured non-invasively by imaging of your heart using an echocardiography (aka ECHO) machine. But the technique depends on the skills of the sonographer (the person who operates the ECHO machine) and can take considerable time to complete.
In view of this limitation, a non-invasive technique that could be used to make the RAP measurements may be more reliable and/or faster than the current technique.
Mespere Lifesciences Inc. has developed a new non-invasive device that is expected to allow for a simple, rapid and reliable measurement of RAP. The device consists of a set of light sensors on a patch that is placed onto the surface of the patient's right side of the neck.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St. Michael's Hospital Patients | – | Device: Mespere Venus 1000 System, Device: Echocardiography machinePatients who are referred to the St. Michael's Hospital echocardiography (ECHO) lab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred to St. Michael's Hospital echocardiography lab
Key inclusion criteria (3 listed)
- Age 18 and older
- Patient referred to St. Michael's Hospital Echocardiography Lab
- Signed written and informed consent
Key exclusion criteria (7 listed)
- Lack of patient consent
- Presence of known AV dialysis fistula
- Allergy to adhesive tape from Mespere Venus 1000 system
- Known central vein stenosis
- Unable to identify right external jugular vein
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 |
|---|---|---|
| Mespere Venus 1000 SystemAn adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with right atrial pressure values obtained by echocardiography(standard clinical practice) | Device | St. Michael's Hospital Patients |
| Echocardiography machineAlso: ECHO machineUse of ultrasound to estimate right atrial pressure from analyzing inferior vena cava (IVC). | Device | St. Michael's Hospital Patients |
Primary outcome
Right atrial pressure (RAP)
Time frame: 0-1 hour
To determine if the RAP from the non-invasive Mespere Venus 1000 System correlates with the RAP from an echocardiography (ECHO) machine
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 15 Aug 2014.
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.
Chi-Ming Chow, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Referred to St. Michael's Hospital Echocardiography Lab, run by Mespere Lifesciences Inc. 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 7 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 15 Aug 2014. 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 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?
Right atrial pressure (RAP) (time frame: 0-1 hour). 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 15 Aug 2014.