Cardisio - detection of heart disease in primary care

Phase 3

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN13922377
• Lead Sponsor: Cardisio UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-07
• Study Completion: 2023-10-23
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 811

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified