Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease

NCT05505344 | Completed

• 1 other identifier: ER45328094
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• V̇O2 peak agreement

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

  Lab visit 30 minutes

Secondary Outcomes (1)

• V̇O2 peak repeatability

  Lab visit 25 minutes

Study Arms (1)

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

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.

Validation lab study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Northumbria University: collaborator
• VentriJect ApS: collaborator

Study Sites (1)

Anna Myers

Sheffield, S9 3TY, United Kingdom

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 26, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

GB (1)