ISRCTN13922377
Completed
Phase 3
Assessing the impact of using community-based heart testing to detect early signs of cardiovascular disease through a novel, quick, low-cost screener which uses sophisticated AI-based analysis
Cardisio UK Ltd0 sites811 target enrollmentJuly 7, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cardisio UK Ltd
- Enrollment
- 811
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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