Diabetics with myocardial infarction Circulatory System
Conditions
Interventions
This is a single-centre, prospective pilot study, limited to working with human blood samples and data with randomisation of patients into one of the two usual prescribing pathways to ensure no select
Sponsors
University of Lincoln
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 years and over 2. Patients with known or new type 2 diabetes mellitus and newly diagnosed acute myocardial infarction 3. Eligible for SGLT2i therapy AND not on an SGLT2i yet 4. The patient is eligible for both prescribing pathways for starting SGLT2i: 4.1. Starting SGLT2i prior to discharge, or 4.2. Starting SGLT2i at follow-up clinic 5. The patient has no preference for a specific prescribing pathway and consents to be randomised 6. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Severe end-stage kidney 3. Severe end-stage liver disease 4. other conditions that would reduce the expected life span of a patient to less than 2 years 5. Unable to provide informed consent 6. Patients who have an indication for early start of, or already prescribed, empagliflozin/other SGLT2i, separate from the above conditions (e.g. patients with known symptomatic heart failure with reduced ejection fraction [EF <40%]) 7. Acute renal failure 8. Cardiogenic shock 9. Severe valvular heart disease 10. Surgical revascularisation 11. Inflammatory related conditions, including infection, cancer, or autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1: Priming/activation of specific inflammatory biomarkers and proteins in the blood (the NLRP3 inflammasome) measured using qRT-PCR, Caspase 1 (Glo) and IL1b assay at Group A t = 0, t = 30, t = 90 and t = 180 days and Group B t = 90, t = 120 and t = 180 days, plus appropriate controls (t=0 and t = 30 days) 2. Cell ageing and tissue damage (senescent cell accumulation and secretory proteins [SASP]), measured using qRT-PCR, Western blotting and ELISA at Group A t = 0, t = 30, t = 90 and t = 180 days. and Group B t = 90, t = 120 and t = 180 days, plus appropriate controls (t = 0 and t = 30 days) 3. Cell behaviour (Cx43 hemichannel-mediated ATP release), measured using carboxyfluorescein dye uptake studies and ATP release assays at Group A t = 0, t = 30, t = 90 and t = 180 days. and Group B t = 90, t = 120 and t = 180days, plus appropriate controls (t = 0 and t = 30 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference in the baseline of activity and the magnitude of the effect of the primary outcome measures NLRP3, Cx43, and SASP correlated to the onset of empagliflozin therapy in AMI, measured using qRT-PCR, Caspase 1 (Glo) and IL1b assays, Western blotting, ELISA, carboxyfluorescein dye uptake studies and ATP release assays on blood samples taken from patients who received empagliflozin prior to discharge; Empa-earlier (Group A, blood sampled at t = 0, 30 and 90 days) vs patients who received empagliflozin at 3 months in follow-up clinic; Empa-later (Group B, blood sampled at t = 90, 120 and 180 days) 2. NLRP3, Cx43 and SASP measured using qRT-PCR, Caspase 1 (Glo) assays, IL1b assays, Western blotting, ELISA, carboxyfluorescein dye uptake studies and ATP release assays at 180 days | — |
Countries
England, United Kingdom
Outcome results
None listed