Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: VentriJect Seismofit validation

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S9 3TY
    • Anna Myers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
V̇O2 peak agreement	Agreement between V̇O2 peak recorded on a maximal CPET and V̇O2 peak estimated using VentriJect Seismofit	Lab visit 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
V̇O2 peak repeatability	Agreement between two V̇O2 peak estimations, recording using VentriJect Seismofit, taken 20 minutes apart	Lab visit 25 minutes

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust; Northumbria University; VentriJect

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ER45328094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No