Cardiovascular disease Circulatory System
Conditions
Interventions
Early detection of CVD
This is a multicentre, partly randomised controlled, non-invasive study, designed with a focus on the application of consistent methods and processes for recruitment and selecti
Sponsors
Cardisio UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 1 or Type 2 diabetes and 1.1. Aged >40 years 1.2. Insulin, metformin, sulphonylureas, alpha-glucosidase inhibitors, prandial glucose regulators, thiazolidinediones or glitazones, GLP-1 analogues (incretin mimetics), DPP-4 and SGLT2 inhibitors, statins 2. Type 1 or Type 2 diabetes aged 18 – 39 years but who have been diagnosed with one or more of the following: 2.1 Retinopathy ranibizumab (Lucentis) and aflibercept (Eylea), steroid medications 2.2 Nephropathy, including persistent microalbuminuria, persistent poor glycaemic control (HbA1c >9%) ACE inhibitors, dapagliflozin, statins, furosemide 3. Elevated blood pressure requiring antihypertensive therapy ACE inhibitor or an angiotensin-2 receptor blocker (ARB), calcium channel blockers such as amlodipine, felodipine, nifedipine, diltiazem and verapamil. Diuretics such as indapamide and bendroflumethiazide. Beta-blockers such as atenolol and bisoprolol. 4. Elevated single risk factor/s, e.g., total cholesterol >6.0 mmol/l statins 5. Features of metabolic syndrome (central obesity and fasting triglycerides) >1.7 mmol/l (non-fasting >2.0 mmol/l) As per medication for blood pressure, blood sugar and cholesterol 6. HDL cholesterol <1.0 mmol/l in men or <1.2 mmol/l in women statins, and ezetimibe, fibrates, bile acid sequestrants and bempedoic acid. Also, injections – such as alirocumab, evolocumab and inclisiran 7. Family history of premature CVD in a first-degree relative Known medication profile of a close family member taking appropriate CVD medication OR 8. QRISK2 =10% or QRISK3 =10%
Exclusion criteria
Exclusion criteria: 1. Already being treated for a CVD-related condition or are symptomatic: combination of anticoagulants, blood thinners, antiplatelets, ACE inhibitors, angiotensin II receptor blockers, beta-blockers, calcium channel blockers, diuretics, vasodilators, nitroglycerin and statins 2. Age under 18 or over 75 years 3. Pregnant 4. Study conflict (participating in other studies) or unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feedback from the test administrators and PIs and reported confidence of the secondary care team of the reliability of the test collected, assessed using data gathered by questionnaires and interviews at the end of the study 2. Ability of the secondary care team to successfully access test results across the study participant group, assessed using questionnaires and interviews at the end of the study 3. The number or percentage of correct predictions (true positives plus true negatives), assessed using data collected in the Cardisio system and the Study Test File gathered at each test and summarised at the end of the study 4. Number of patient journeys saved and carbon reduction estimated using postcode information at the end of the study 5. Feedback from CI and secondary team plus feedback from GP/PCN PI gathered by questionnaire and interviews at the end of the study 6. Feedback from participant surveys, feedback from PIs in pharmacy setting and analysis of referrals made, and feedback from CI and secondary care team, gathered by questionnaire and interviews. Participant questionnaires taken just before and just after the test. Other data collected during the study and analysed and summarised at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ease with which the primary care administrators can undertake recruitment selection and testing of study participants as recorded in the “Participant Testing Log”, assessed by questionnaire and interviews at the end of the study 2. Feedback on the ease of training in person and online training materials from PIs and test administrators gathered via survey and structured interviews at the end of the study 3. Feedback on the ease of test procedure and administration from PIs and test administrators gathered via survey and structured interviews at the end of the study 4. Feedback on patient experience and preference for community-based testing gathered via pre and post-test surveys at the time of each test 5. The view of the secondary care (cardiology) team of the process and impact on the quality of their patient lists, gathered via survey and structured interviews at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed