Coronary Heart DiseaseNCT05505344
Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease
An observational study of Coronary Heart Disease, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
In people living with coronary heart disease (CHD), V̇O2 peak predicts all-cause mortality. V̇O2 peak increases with regular exercise training. Thus, in exercise-based cardiovascular rehabilitation programmes, V̇O2 peak is a useful marker of how effective the exercise training has been. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- VentriJect Seismofit validation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Aug 2022to 20 Feb 2023
- 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
- Adult, Older adult
Study population: Adults with coronary heart disease currently enrolled in a Phase IV cardiac rehabilitation programme
Who may be able to join
- Stable coronary heart disease
- Able to lay fully supine for five minutes
- Capable of performing a maximum effort CPET on a stationary cycle ergometer
- Currently enrolled in a Phase IV cardiac rehabilitation programme
- A minimum of 12 weeks after a cardiac event
Who cannot join
- Awaiting any significant medical investigations relating to CPET absolute contraindications
- Hospitalisation within the last 4 weeks relating to CPET absolute contraindications
- Implantable cardiac devices e.g. pacemaker or implantable cardioverter defibrillator
- Unstable angina
- Unstable diabetes
- Left main coronary stenosis or its equivalent
Show all 22Show fewer
- Known third degree heart block
- Unstable heart failure/New York Heart Association (NYHA) III or IV Heart Failure
- Acute aortic dissection, myocarditis, or pericarditis/endocarditis
- Suspected or known dissecting aneurysm
- Symptomatic severe aortic stenosis
- Acute deep vein thrombosis, pulmonary embolism or pulmonary infection
- Uncontrolled asthma
- Pulmonary oedema
- Respiratory failure
- Ambient O2 desaturation at rest <85%
- Resting tachycardia (>100bpm)
- Currently in atrial fibrillation
- Uncontrolled arrhythmia
- Resting systolic blood pressure >180 mmHg
- Resting diastolic blood pressure >100 mmHg
- Other conditions that prevent participants from completing study investigations (e.g. recent (last ~6 months) cardiac arrest)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Validity of Seismofit® for Estimating Peak Oxygen Uptake in People With Coronary Heart Disease
In people living with coronary heart disease (CHD), V̇O2 peak predicts all-cause mortality. V̇O2 peak increases with regular exercise training. Thus, in exercise-based cardiovascular rehabilitation programmes, V̇O2 peak is a useful marker of how effective the exercise training has been.
Maximal cardiopulmonary exercise testing (CPET) is the gold standard method of measuring V̇O2 peak. However, maximal CPET is expensive and requires trained staff to conduct the test and interpret the results. Furthermore, CPET is not routinely available in United Kingdom (UK) cardiovascular rehabilitation programmes. Field exercise tests, such as incremental cycle ergometer tests, are used in conjunction with predictive equations to estimate V̇O2 peak. However, this group has shown that estimating changes in V̇O2 peak in this way is inaccurate. Alternative solutions are required.
VentriJect Seismofit® uses a technique called seismocardiography (SCG); the measurement of vibrations in the chest wall, caused by each heartbeat, using accelerometers. SCG can be used to estimate V̇O2 peak from a SCG measurement taken at rest. This study will explore the validity of VentriJect Seismofit for estimating V̇O2 peak in people with CHD.
- Conditions
- Coronary Heart Disease
- Being tested
- VentriJect Seismofit validation
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentriJect Seismofit validationDevice
All participants will have a resting and exercising electrocardiogram (ECG) trace and a lung function test, called spirometry, will be performed. They will take part in a maximal CPET to determine V̇O2 peak. Participants will also have their V̇O2 peak estimated twice, twenty minutes apart, using the VentriJect Seismofit device. A short questionnaire will be administered to explore the acceptability of completing a maximal CPET and having V̇O2 peak estimated using VentriJect Seismofit.
| Study group | Role | What they receive |
|---|---|---|
| Validation lab study | All participants will have a resting and exercising electrocardiogram (ECG) trace and a lung function test, called spirometry, will be performed. They will take part in a maximal CPET to determine V̇O2 peak. Participants will also have their V̇O2 peak estimated twice, twenty minutes apart, using the VentriJect Seismofit device. A short questionnaire will be administered to explore the acceptability of completing a maximal CPET and having V̇O2 peak estimated using VentriJect Seismofit. Receives: Device: VentriJect Seismofit validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
V̇O2 peak agreement
Agreement between V̇O2 peak recorded on a maximal CPET and V̇O2 peak estimated using VentriJect Seismofit
Measured: Lab visit 30 minutes
Secondary outcomes (1)
V̇O2 peak repeatability
Agreement between two V̇O2 peak estimations, recording using VentriJect Seismofit, taken 20 minutes apart
Measured: Lab visit 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start26 Aug 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Northumbria University, VentriJect ApS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505344
- Sponsor's protocol ID
- ER45328094
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Validity of Seismofit® for Estimating Peak Oxygen Uptake in People With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT05505344
- Acronym / sponsor ID
- ER45328094
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Northumbria University, VentriJect ApS
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 17 Aug 2022 (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.
In people living with coronary heart disease (CHD), V̇O2 peak predicts all-cause mortality. V̇O2 peak increases with regular exercise training. Thus, in exercise-based cardiovascular rehabilitation programmes, V̇O2 peak is a useful marker of how effective the exercise training has been.
Maximal cardiopulmonary exercise testing (CPET) is the gold standard method of measuring V̇O2 peak. However, maximal CPET is expensive and requires trained staff to conduct the test and interpret the results. Furthermore, CPET is not routinely available in United Kingdom (UK) cardiovascular rehabilitation programmes. Field exercise tests, such as incremental cycle ergometer tests, are used in conjunction with predictive equations to estimate V̇O2 peak. However, this group has shown that estimating changes in V̇O2 peak in this way is inaccurate. Alternative solutions are required.
VentriJect Seismofit® uses a technique called seismocardiography (SCG); the measurement of vibrations in the chest wall, caused by each heartbeat, using accelerometers. SCG can be used to estimate V̇O2 peak from a SCG measurement taken at rest. This study will explore the validity of VentriJect Seismofit for estimating V̇O2 peak in people with CHD.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation lab study | – | Device: VentriJect Seismofit validationAll participants will have a resting and exercising electrocardiogram (ECG) trace and a lung function test, called spirometry, will be performed. They will take part in a maximal CPET to determine V̇O2 peak. Participants will also have their V̇O2 peak estimated twice, twenty minutes apart, using the VentriJect Seismofit device. A short questionnaire will be administered to explore the acceptability of completing a maximal CPET and having V̇O2 peak estimated using VentriJect Seismofit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with coronary heart disease currently enrolled in a Phase IV cardiac rehabilitation programme
Key inclusion criteria (5 listed)
- Stable coronary heart disease
- Able to lay fully supine for five minutes
- Capable of performing a maximum effort CPET on a stationary cycle ergometer
- Currently enrolled in a Phase IV cardiac rehabilitation programme
- A minimum of 12 weeks after a cardiac event
Key exclusion criteria (22 listed)
- Awaiting any significant medical investigations relating to CPET absolute contraindications
- Hospitalisation within the last 4 weeks relating to CPET absolute contraindications
- Implantable cardiac devices e.g. pacemaker or implantable cardioverter defibrillator
- Unstable angina
- Unstable diabetes
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 |
|---|---|---|
| VentriJect Seismofit validationAll participants will have a resting and exercising electrocardiogram (ECG) trace and a lung function test, called spirometry, will be performed. They will take part in a maximal CPET to determine V̇O2 peak. Participants will also have their V̇O2 peak estimated twice, twenty minutes apart, using the VentriJect Seismofit device. A short questionnaire will be administered to explore the acceptability of completing a maximal CPET and having V̇O2 peak estimated using VentriJect Seismofit. | Device | Validation lab study |
Primary outcome
V̇O2 peak agreement
Time frame: Lab visit 30 minutes
Agreement between V̇O2 peak recorded on a maximal CPET and V̇O2 peak estimated using VentriJect Seismofit
1 secondary outcome
V̇O2 peak repeatability
Time frame: Lab visit 25 minutes
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 1 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Heart Disease, run by Sheffield Hallam University at 1 site in United Kingdom.
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 5 inclusion and 22 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 1 Dec 2023. 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 Kingdom. 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?
V̇O2 peak agreement (time frame: Lab visit 30 minutes). 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 1 Dec 2023.