Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505344
• Other study ID #: ER45328094
• Status: Completed
• Start date: August 26, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: November 2023
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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 V?O2 peak. Participants will also have their V?O2 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 V?O2 peak estimated using VentriJect Seismofit.

Locations

Country	Name	City	State
United Kingdom	Anna Myers	Sheffield

Sponsors (4)

Lead Sponsor	Collaborator
Sheffield Hallam University	Northumbria University, Sheffield Teaching Hospitals NHS Foundation Trust, VentriJect

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	V?O2 peak agreement	Agreement between V?O2 peak recorded on a maximal CPET and V?O2 peak estimated using VentriJect Seismofit	Lab visit 30 minutes
Secondary	V?O2 peak repeatability	Agreement between two V?O2 peak estimations, recording using VentriJect Seismofit, taken 20 minutes apart	Lab visit 25 minutes