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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Muhammad Usman
Shah
+44 (0)1522 512512
muhammadusman.shah@ulh.nhs.uk
Prof
Kelvin
Lee
+44 (0)1522 512512
kelvin.lee@ulh.nhs.uk
Type 2 diabetes mellitus, ischaemic heart disease, acute coronary syndrome.
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
People with diabetes are at increased risk of major complications such as heart and kidney damage, which are responsible for the majority of deaths in patients with this disorder. Additionally, patients with diabetes who have had a heart attack have a 2-3-fold increased risk of mortality compared to those without diabetes, not only during the acute event but long after surviving the initial event. Sodium-glucose co-transporter-2 inhibitors (SGLT2i), are prescribed to help control blood sugar levels in type-2 diabetes mellitus (T2DM). These drugs, which are safe and well tolerated, have also shown significant cardiovascular benefits reducing mortality, heart failure, heart attack, and strokes in T2DM patients. However the optimal starting time in patients with T2DM in the context of acute myocardial infarction (AMI) is unclear. As a result, there is variability in the practice of starting these medications following a heart attack, with some being started prior to discharge or at 3 months (early-intervention), or much later at 6-12 months (late-intervention) but in reality many were missed altogether (missed-intervention). This was the fundamental reason that led to the formation of the cardio-metabolic program at the Lincolnshire Heart Centre. Determining any benefit from an early start (before discharge or at 6 months) would potentially reduce further events and hospitalisations which would improve the quality of life for patients, as well as reduce the burden on our health care system. This study will assess whether there is any benefit of an early start of SGLT2i in T2DM patients with AMI.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Type 1 DM (as the safety of SGLT2i in this group is still not known and therefore, not recommended currently)2. Non-diabetics3. Prediabetics4. 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 months8. 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Kelvin
Lee
+44 (0)1522 512512
kelvin.lee@ulh.nhs.uk
Dr
Muhammad Usman
Shah
+44 (0)1522 512512
muhammadusman.shah@ulh.nhs.uk
The study is sponsored by University of Lincoln and funded by Lincolnshire Heart Centre.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
