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Completed

NCT Number: NCT05505344

Estimating Peak Oxygen Uptake in People Living 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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anna Myers

Sheffield, S9 3TY, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

VentriJect Seismofit validation

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. V̇O2 peak repeatability

    Time frame: Lab visit 25 minutes

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

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Northumbria University
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • VentriJect ApS

Registry information

Official study title

Exploring the Validity of Seismofit® for Estimating Peak Oxygen Uptake in People With Coronary Heart Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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