Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Sponsor
- German Diabetes Center
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Change of cardiac function
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the prospective observational DISTEMI-Study in people with and without Diabetes mellitus (DI) after new onset of ST-Segment Elevation Myocardial Infarction (STEMI) aged 18-80 years at inclusion into the study is to characterize in detail the clinical, metabolical, immunological and vascular phenotype, investigate the interplay between myocardial remodelling and the metabolic phenotype, monitor the progression of the disease and compare the phenotype of STEMI people with diabetes mellitus to people with prediabetes and glucose tolerant people.
Detailed Description
In detail, the following questions will be answered: 1. Do distinct metabolic phenotypes (with respect to insulin secretion, insulin sensitivity, circulating free fatty acids and ectopic lipid storage, especially in the liver) determine myocardial infarct size and decline of contractile function of the remote myocardium? 2. Which factors modify the progression of the disease (insulin resistance, ectopic lipid storage, subclinical inflammation, abnormal energy metabolism)? People are thoroughly examined at baseline and one year after STEMI. 3. Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes? 4. Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?
Investigators
Eligibility Criteria
Inclusion Criteria
- •Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
- •Age 18-80 years
- •HbA1c \<9.0%
- •People with diagnosis of diabetes mellitus according to ADA and DDG criteria (i.e. HbA1c ≥6.5% and/or pathological oral glucose tolerance test)
- •Healthy people with normal glucose tolerance status according to ADA and DDG criteria (i.e. HbA1c \<5.7% and normal OGTT)
- •People with impaired glucose metabolism ("prediabetes") according to ADA and DDG criteria (i.e. impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
- •Consent-able, hemodynamically stable people, without sedation (e.g. opiates) or other interfering medication (e.g. catecholamines)
Exclusion Criteria
- •Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
- •Current pregnancy
- •Infectious diseases, acute infections / fever
- •Immunosuppressive therapy
- •Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
- •Malignant diseases
- •Severe chronic psychiatric illness or addiction
- •Participation in an intervention trial
Outcomes
Primary Outcomes
Change of cardiac function
Time Frame: One year
Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging
Secondary Outcomes
- Change of liver stiffness(One year)
- Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities(One year)
- Change of insulin sensitivity (M-Value)(One year)
- Change of ectopic fat distribution(One year)
- Change of energy metabolism(One year)
- Change of mitochondrial respiratory function(One year)
- Change of Homeostasis Model Assessment 2 Estimate(One year)
- Change of insulin secretion(One year)
- Change of Fatty liver index(One year)