CClinicalTrials.gg
CompletedNCT05505344Updated Dec 1, 2023

Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease

An observational study in Coronary Heart Disease, sponsored by Sheffield Hallam University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by Sheffield Hallam University · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 20 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Sheffield Hallam University is the lead sponsor of 44 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adults with coronary heart disease currently enrolled in a Phase IV cardiac rehabilitation programme

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: VentriJect Seismofit validation

Interventions

  • DeviceVentriJect Seismofit validation

    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.

06

What researchers measure

Primary outcomes

  1. V̇O2 peak agreement

    Agreement between V̇O2 peak recorded on a maximal CPET and V̇O2 peak estimated using VentriJect Seismofit

    Time frame: Lab visit 30 minutes

Secondary outcomes

  1. V̇O2 peak repeatability

    Agreement between two V̇O2 peak estimations, recording using VentriJect Seismofit, taken 20 minutes apart

    Time frame: Lab visit 25 minutes

07

Study locations

1 site
  • Anna Myers
    Sheffield, S9 3TY, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05505344
Lead sponsor
Sheffield Hallam University
Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust, Northumbria University, VentriJect
Responsible party
Sponsor
First posted
Aug 17, 2022
Start date
Aug 26, 2022
Primary completion
Feb 20, 2023
Completion
Feb 20, 2023
Last update
Dec 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion