Type 2 diabetes mellitus, ischaemic heart disease, acute coronary syndrome. Nutritional, Metabolic, Endocrine
Conditions
Interventions
Patient-related clinical information as stated in the protocol, is collected as part of the local cardiodiabetic database, which is regularly updated from the local MINAP database and electronic healt
Sponsors
University of Lincoln
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years and older (no upper age limit) 2. Male or female 3. Type 1 acute myocardial infarction (AMI) (both ST elevation and Non-ST elevation MI) as per the 4th Universal definition of myocardial infarction 4. Known or newly diagnosed type 2 Diabetes Mellitus 5. Successful discharge from the hospital after the index event
Exclusion criteria
Exclusion criteria: 1. Type 1 DM (as the safety of SGLT2i in this group is still not known and therefore, not recommended currently) 2. Non-diabetics 3. Prediabetics 4. Current pregnancy (contraindication for SGLT2i use) 5. Breastfeeding (contraindication for SGLT2i use) 6. End-stage kidney with a life expectancy of fewer than 6 months, including GFR,15 ml/min/1.73 m2 (making SGLT2i contraindicated) 7. End-stage liver disease life expectancy of less than 6 months 8. Death in hospital at index event (First heart attack for the duration of the study) 9. Non-cardiovascular conditions, such as advanced malignancy, that will result in a life expectancy of less than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A combined outcome of cardiovascular death, non-fatal MI, non-fatal stroke, and hospitalisation of heart failure in patients with type 2 diabetes mellitus and acute myocardial infarction and early (before discharge to 6 months) versus late (6-12 months) or missed initiation (>12months/never) of SGLT2i | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be measured using from patient’s medical notes at one timepoint: 1. Time to all-cause death 2. Time to CV death 3. Time to first nonfatal MI or nonfatal cerebrovascular accident (CVA) 4. Time to first unplanned coronary revascularisation 5. Time to the first episode of hospitalisation for heart failure 6. Composite Renal outcomes including doubling of serum creatinine, or eGFR = 15 mL/min/1.73m2, or the initiation of permanent renal replacement therapy or death due to renal disease 7. SGLT2i Safety Profile as a composite of reported hypoglycaemia, postural hypotension, diabetic ketoacidosis, acute kidney injury, urinary tract infection, mycotic genital infections, diabetic foot emergencies, amputations (digital/limb) or Fournier’s gangrene 8. Net overall benefit as an assessment of overall benefit versus overall harm observed | — |
Countries
England, United Kingdom
Contacts
Public ContactMuhammad Usman Shah
Outcome results
None listed