Cardiovascular disease (CVD) or elevated cardiovascular risk Circulatory System
Conditions
Interventions
Potential participants will be identified by a member of their NHS clinic health care team. Potential participants will be asked at their clinic visit if they would be willing to speak to a member of
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: For all participants in Part A and Part B: 1. Age = 18 years at the time of signing informed consent 2. Confirmed diagnosis of cardiovascular disease or elevated cardiovascular risk, including, but not limited to, atherosclerotic cardiovascular disease, hypertension, hyperlipidaemia (Investigator opinion) 3. Able to participate in all planned study visits 4. Able to understand the nature, objectives, and procedures of the study, and to provide written informed consent before any study-related procedures 5. Willingness and capacity to comply with all protocol-required activities, including blood sample collection using venepuncture and PCmS using a Tasso+ device In addition, for participants in Part B (self-collection or assisted self-collection): 1. Access to a stable home environment suitable for sample collection 2. Able to follow written or visual instructions for the Tasso+ device and associated sampling kit, with assistance from a family member or a caregiver, if required 3. Ability to comply with sample labelling, packing, and returning by post, as specified in participant instructions
Exclusion criteria
Exclusion criteria: 1. Presence of any medical, psychological, or social condition or treatment that, in the opinion of the investigator, may interfere with the participant’s ability to comply with any study procedures or may increase the risk associated with study participation 2. Presence of any skin infection or damage at the intended sample collection sites 3. History of hypersensitivity to skin adhesives, e.g., sticking plasters or dressings 4. Enrolment in another clinical study or trial involving interventions that, in the investigator’s judgment, could interfere with the endpoints of the Project-COMFORT study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Concentrations of selected analytes in venous and PCmS-collected blood samples measured using Laboratory Analysis at Day 1;Part B: 1. Percentage of participants who successfully perform at least one PCmS self-collection according to instructions. 2. Percentage of participants who successfully perform three PCmS self-collections according to instructions. 3. Percentage of self-collected PCmS samples fulfilling expected laboratory quality criteria (e.g., volume, time frame for shipping/receiving, haemolysis/clotting, and suitability for analysis). measured using Laboratory analysis and questionnaires at Day 1, Day 7 and Day 14 | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactIsla Mackenzie
Outcome results
None listed