Cardiovascular Risk FactorNCT02636023
Correlation Between the SPhENo-Cardiograph™, a Seismocardiograph Device, and GE Vivid Q, an Echocardiograph, for Known Systemic Timing Intervals (STI)
A study testing SPhENo-Cardiograph in people with Cardiovascular Risk Factor, run by Heart Force Medical Inc. at 1 site in Canada.
Trial summary
The study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device called the SPhENo-CardiographTM. The SPhENo-Cardiograph™ provides a non-invasive assessment of the electro-mechanical function of the heart. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- SPhENo-Cardiograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Aug 2015
- 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
- Able to understand the informed consent document
- Willing to participate in study
- Ambulatory volunteer
Who cannot join
- Individuals with visible scar(s) or deformity in the test area of the chest
- Non-ambulatory subjects
- Previously diagnosed with life-threatening condition (e.g. cancer)
- Known or diagnosed psychiatric condition
- Enrolled in a concurrent study or trial
- Exercised excessively within the last 4 hours (prior to study visit)
Show all 9Show fewer
- Consumption of caffeine containing drinks within the previous 4 hours
- Unwilling to sign Informed Consent
- Female subjects who are pregnant, suspected or planning to become pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
Canada1 site
Boucher Institute of Naturopathic Medicine
New Westminster, British Columbia, V3L 5N8
About this study
Official title: A Clinical Study to Determine the Correlation Between the SPhENo-Cardiograph™, a Seismocardiograph Device, and GE Vivid Q, an Echocardiograph, for Known Systemic Timing Intervals (STI).
The study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device called the SPhENo-CardiographTM. The SPhENo-Cardiograph™ provides a non-invasive assessment of the electro-mechanical function of the heart. The electrocardiograph (ECG) represents the waveform of the electrical stimulus to the cardiac muscle. The mechanical actions of the electrical potentials delivered in the ECG are revealed as the seismocardiograph (SCG). The SCG represents the changes in acceleration of the heart during the cardiac cycle. The SCG waveform reflects the ultra-low frequency vibrations of cardiac contraction. These low frequency vibrations are transmitted through the sternum. Using the point of initiation of ventricular contraction on the ECG, the Q wave, with fiduciary points on the synchronous seismocardiograph, it is possible to determine timing events of the cardiac cycle. The timing events of the cardiac cycle during systole are referred to as Systolic Timing Intervals (STI) and comprise the Pre-Ejection Period (PEP) and the Left Ventricular Ejection Time (LVET). The PEP is the time from the Q wave to the Aortic valve opening. The Left Ventricular Eject Time (LVET) is the time between the Aortic Valve opening and closing. The ratio of PEP/LVET in individuals with established heart disease is > 0.42. It is based on the formula described by Dr Arnold Weissler and first published in Circulation in 1968 (Weissler et al,1968). Weissler et al showed that the PEP/LVET ratio >0.42 are indicative of a lengthening of the PEP with some marginal shortening of the LVET. This is indicative of pathology associated with the coronary circulation (Ahmed et al, 1972;). This ratio can then be used as part of a non-invasive quantitative assessment of cardiac performance (Lewis et al 1977).
Using the SPhENo-CardiographTM, HFM has developed an algorithm to assess heart health that otherwise requires a number of technologies; stethoscope, ECG and Carotid pulse tracing to identify the dicrotic notch or Aortic Valve closure.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- SPhENo-Cardiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPhENo-CardiographDevice
SPhENo-Cardiograph
| Study group | Role | What they receive |
|---|---|---|
| SPhENo-Cardiograph / ECG | Experimental | SPhENo-Cardiograph and ECG Receives: Device: SPhENo-Cardiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient ≥0.8 between STI ratio values determined by the SPhENo-Cardiograph™ and an echocardiograph
Measured: 1 day
Correlation coefficient ≥0.8 between PEP values determined by the SPhENo-Cardiograph™ and an echocardiograph
Measured: 1 day
Correlation coefficient ≥0.8 between LVET values determined by the SPhENo-Cardiograph™ and an echocardiograph
Measured: 1 day
Correlation coefficient ≥0.8 between heart rate values determined by the SPhENo-Cardiograph™ and an echocardiograph
Measured: 1 day
Secondary outcomes (6)
Correlation coefficient ≥0.8 between STI ratio values determined by the SPhENo-Cardiograph™ and a manual analysis
Measured: 1 day
Correlation coefficient ≥0.8 between PEP values determined by the SPhENo-Cardiograph™ and a manual analysis
Measured: 1 day
Correlation coefficient ≥0.8 between LVET values determined by the SPhENo-Cardiograph™ and a manual analysis
Measured: 1 day
Correlation coefficient ≥0.8 between heart rate values determined by the SPhENo-Cardiograph™ and a manual analysis
Measured: 1 day
Safety and tolerability assessed by Adverse event collection
Adverse event collection
Measured: 1 day
Subject questionnaire
Questionnaire to evaluate relevance of device from subject's perspective; data to be analyzed qualitatively
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Force Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karrin Fairman Young, ND, Principal investigator, Boucher Institute of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636023
- Sponsor's protocol ID
- SPHENO_CLIN_003
- Status last verified
- Feb 2016
- First submitted
- 22 Oct 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Determine the Correlation Between the SPhENo-Cardiograph™, a Seismocardiograph Device, and GE Vivid Q, an Echocardiograph, for Known Systemic Timing Intervals (STI).
- ClinicalTrials.gov ID
- NCT02636023
- Acronym / sponsor ID
- SPHENO_CLIN_003
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Heart Force Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Dec 2015 (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 study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device called the SPhENo-CardiographTM. The SPhENo-Cardiograph™ provides a non-invasive assessment of the electro-mechanical function of the heart. The electrocardiograph (ECG) represents the waveform of the electrical stimulus to the cardiac muscle. The mechanical actions of the electrical potentials delivered in the ECG are revealed as the seismocardiograph (SCG). The SCG represents the changes in acceleration of the heart during the cardiac cycle. The SCG waveform reflects the ultra-low frequency vibrations of cardiac contraction. These low frequency vibrations are transmitted through the sternum. Using the point of initiation of ventricular contraction on the ECG, the Q wave, with fiduciary points on the synchronous seismocardiograph, it is possible to determine timing events of the cardiac cycle. The timing events of the cardiac cycle during systole are referred to as Systolic Timing Intervals (STI) and comprise the Pre-Ejection Period (PEP) and the Left Ventricular Ejection Time (LVET). The PEP is the time from the Q wave to the Aortic valve opening. The Left Ventricular Eject Time (LVET) is the time between the Aortic Valve opening and closing. The ratio of PEP/LVET in individuals with established heart disease is > 0.42. It is based on the formula described by Dr Arnold Weissler and first published in Circulation in 1968 (Weissler et al,1968). Weissler et al showed that the PEP/LVET ratio >0.42 are indicative of a lengthening of the PEP with some marginal shortening of the LVET. This is indicative of pathology associated with the coronary circulation (Ahmed et al, 1972;). This ratio can then be used as part of a non-invasive quantitative assessment of cardiac performance (Lewis et al 1977).
Using the SPhENo-CardiographTM, HFM has developed an algorithm to assess heart health that otherwise requires a number of technologies; stethoscope, ECG and Carotid pulse tracing to identify the dicrotic notch or Aortic Valve closure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPhENo-Cardiograph / ECG | Experimental | Device: SPhENo-CardiographSPhENo-Cardiograph and ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand the informed consent document
- Willing to participate in study
- Ambulatory volunteer
Key exclusion criteria (9 listed)
- Individuals with visible scar(s) or deformity in the test area of the chest
- Non-ambulatory subjects
- Previously diagnosed with life-threatening condition (e.g. cancer)
- Known or diagnosed psychiatric condition
- Enrolled in a concurrent study or trial
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 |
|---|---|---|
| SPhENo-CardiographSPhENo-Cardiograph | Device | SPhENo-Cardiograph / ECG |
Primary outcome
Correlation coefficient ≥0.8 between STI ratio values determined by the SPhENo-Cardiograph™ and an echocardiograph
Time frame: 1 day
Correlation coefficient ≥0.8 between PEP values determined by the SPhENo-Cardiograph™ and an echocardiograph
Time frame: 1 day
Correlation coefficient ≥0.8 between LVET values determined by the SPhENo-Cardiograph™ and an echocardiograph
Time frame: 1 day
Correlation coefficient ≥0.8 between heart rate values determined by the SPhENo-Cardiograph™ and an echocardiograph
Time frame: 1 day
6 secondary outcomes
Correlation coefficient ≥0.8 between STI ratio values determined by the SPhENo-Cardiograph™ and a manual analysis
Time frame: 1 day
Correlation coefficient ≥0.8 between PEP values determined by the SPhENo-Cardiograph™ and a manual analysis
Time frame: 1 day
Correlation coefficient ≥0.8 between LVET values determined by the SPhENo-Cardiograph™ and a manual analysis
Time frame: 1 day
Correlation coefficient ≥0.8 between heart rate values determined by the SPhENo-Cardiograph™ and a manual analysis
Time frame: 1 day
Safety and tolerability assessed by Adverse event collection
Time frame: 1 day
Subject questionnaire
Time frame: 1 day
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 11 Feb 2016.
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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.
Karrin Fairman Young, ND principal investigator
Boucher Institute of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPhENo-Cardiograph in people with Cardiovascular Risk Factor, run by Heart Force Medical 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 9 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 11 Feb 2016. 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?
Correlation coefficient ≥0.8 between STI ratio values determined by the SPhENo-Cardiograph™ and an echocardiograph (time frame: 1 day). The study lists 4 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 11 Feb 2016.