Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease
NCT ID: NCT05505344
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2022-08-26
2023-02-20
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Northumbria University
OTHER
VentriJect ApS
INDUSTRY
Sheffield Hallam University
OTHER
Responsible Party
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Locations
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Anna Myers
Sheffield, , United Kingdom
Countries
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Other Identifiers
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ER45328094
Identifier Type: -
Identifier Source: org_study_id