Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01472133
Eligibility Criteria:
Inclusion Criteria:
* Young Healthy Volunteers
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged between 18 and 40 years old.
* Older Healthy Volunteers
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 70 years or above.
* Patients
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18-70 years old.
* Participant has one of the following conditions:
* Atrial fibrillation
* A permanent pacemaker that is continuously active
* Reduced chest wall movement
Exclusion Criteria:
* Young Healthy Volunteers
* Any condition which might increase the risk of exercise testing
* Any history of ischaemic heart disease
* Any history of heart failure
* Any structural heart disease (eg: valvular lesions, hypertrophic obstructive cardiomyopathy)
* Any abnormalities on a resting ECG
* Deep vein thrombosis diagnosed within the last 6 months or under active treatment
* Uncontrolled hypertension (systolic blood pressure \>220 mm Hg, diastolic \>120 mm Hg)
* Aortic aneurysm
* Aortic or cardiovascular surgery within 6 months of recruitment
* A family history of sudden cardiac death, congenital arrhythmia syndromes or cardiomyopathy
* Autonomic dysfunction, either previously diagnosed or upon testing by the research team
* Any condition involving the brain or spinal cord
* Diabetes
* Alcohol consumption \> 21 units/week for women and 28 units/week for men or a history of previous alcohol dependence.
* Acute kidney injury
* Chronic kidney disease stage 4 or 5
* Any condition causing hepatic dysfunction
* Presence of a permanent pacemaker (these participants would be eligible for the pacemaker group)
* Reduced chest wall movement (these participants would be eligible for the reduced chest movement group)
* Any acute infection requiring antibiotic treatment within 3 months of recruitment
* Any other surgery or illness requiring hospitalisation within 3 months of recruitment
* Currently taking any medication with the exception of analgesics or the oral contraceptive pill.
* Any wound or skin condition affecting the torso which may be affected by the application of adhesive ECG dots to the skin
* Pregnancy
* Inability to give informed consent
* Older Healthy Volunteers
* Any diagnosed condition primarily affecting the cardiovascular or respiratory systems
* Symptomatic autonomic dysfunction
* Orthostatic hypotension
* Any condition involving the brain or spinal cord
* Diabetes
* Alcohol consumption \> 21 units/week for women and 28 units/week for men or a history of previous alcohol dependence.
* Acute kidney injury
* Chronic kidney disease stage 4 or 5
* Any condition causing hepatic dysfunction
* Presence of a permanent pacemaker
* Chronic Obstructive Pulmonary Disease (COPD).
* Any muscular dystrophy
* Kyphosis
* Scoliosis
* Pectus excavatum
* Any disease involving the lungs or pleura
* Any acute infection requiring antibiotic treatment within 3 months of recruitment
* Any other surgery or illness requiring hospitalisation within 3 months of recruitment
* Currently taking any medication with the exception of analgesics or the oral contraceptive pill.
* Any wound or skin condition affecting the torso which may be affected by the application of adhesive ECG dots to the skin
* Pregnancy
* Inability to give informed consent
* Patients
* Any infection which would require isolation or barrier nursing according to the hospital's infection control policy
* Any wound or skin condition affecting the torso which may be affected by the application of adhesive ECG dots to the skin
* Requirement for any form of artificial ventilatory support, including oxygen therapy
* More than one of the inclusion criteria. (ie: a patient may not have both atrial fibrillation and reduced chest wall movement and be eligible for this study)
* Inability to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Study:
NCT01472133
Study Brief:
Protocol Section:
NCT01472133