I21 I61 I63 E11 N17 I67.6 H34.1 H47.0 G45.0 G45.1 G45.2 G45.3 G45.9 I11.0 I13.0 I13.2 I13.9 I42 I50.0 I50.13 I50.14 I50.19 I50.9
Conditions
Interventions
Group 1: Patients with acute myocardial infarction, after acute decompensated heart failure, after acute stroke, with acute kidney failure or with type 2 diabetes mellitus will be followed up over 10
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: provision of signed and dated informed consent form 2) declared willingness to take part in study procedures and to be contacted again for further follow-up examinations 3) persons of any sex and gender, aged 18 years or above at the time of acute event or study inclusion 4) general health status is acceptable for participation in a study 5) clinical diagnosis of one or more of the following diseases: A) acute heart failure (trigger event), defined by: i) dyspnoe NYHA IIIb or IV and NTproBNP = 300 pg/nl OR MRproANP = 120 pmol/l, AND ii) evidence of pitting peripheral edema or radiological or clinical signs of of pulmonary congestion, AND iii) Need for i.v.-administration or dose escalation of diuretic therapie equivalent to furosemid 40 mg or torasemid of 10 mg. B) acute coronary syndrome (trigger event), defined by: i) acute cardiac chest pain, or angina equivalent consistent with moderate to high- risk unstable angina or myocardial infarction, lasting more than 10 minutes duration during72 hours before invasive examination, AND ii) evidence for ACS requiring catheterization documented by (1) elevated enzymes (CK-MB or hs-troponin i/T >99th percentile or in- /decrease) AND/OR (2) ECG with ST-depression >1mm in 2 or more contiguous leads after the J-point AND/OR (3) transient ST-elevation >1mm in 2 or more contiguous leads lasting 30 min ST-elevation > 1mm in 2 or more contiguous leads or new left bundle block C) acute cerebrovascular disorders (trigger event), defined by: i) a transient ischemic attack (TIA) with clinical restitution within 24h AND initial neurological deficit verified by a neurologist OR ABCD2-Score >= 3 OR visibleDWI-lesion (MRI) OR the main hospital diagnosis of Amaurosis fugax ii) Ischemic stroke including retinal central artery occlusion iii) stroke caused by non-traumatic intracerebral hemorrhage iv) stroke caused by cerebral venous thrombosis D) acute kidney injury while hospitalized, that occurred 3-8 days before study inclusion (trigger event), defined by: i) >= 2fold increase in creatinine compared to a respective value during a presumed or documented time period (stage 2 or 3 acute kidney injury according to KDIGO) ii) persistence of the increased value for at least 72 hrs E) diabetes mellitus type 2 (at day 60) i) known diabetes mellitus type 2 characterized by (1) pathological findings in oral glucose tolerance test, OR (2) documented HbA1c >= 6.5%, OR (3) Intake of any antidiabetic medication ii) prediabetes with high cardiovascular risk, characterized by (1) HbA1c >5.7% and = 5
Exclusion criteria
Exclusion criteria: 1) lack of capacity to give informed consent 2) pregnancy or lactation 3) life expectancy < 6 months due to non-cardio-/cerebrovascular diseases or conditions 4) organ transplanted 5) Lack of health insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint consisting of: cardiovascular mortality, non-fatal stroke, non-fatal myoracial infarction, rehospitalization due to heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiovascular morbidity (cardiac insufficiency, coronary heart disease, revascularization, TIA. Myocardial infarction or stroke are appraised as secondary instead of primary endpoints when the composite primary endpoint has already been reached beforehand). 2. overall mortality. 3. course / manifestation of cardiovascular risk factors (glucose, lipids, blood pressure, renal insufficiency, etc.). 4. the importance of the physical condition (for example, dexterity) on health-related quality of life, tendency to fall, age dependency and on new cardiovascular Events. 5. Significance of cognitive (e.g., memory) and mental (e.g., depressive) condition related to health-related quality of life, tendency to fall, retirement, and new cardiovascular events, 6. manifestation of atrial fibrillation. 7. Independency in everyday life (by degree of nursing). 8. intra-abdominal, intra-myocellular and intra-hepatic fat. 9. Significance of glucose variability (inter-day and intra-day) with respect to cardiovascular outcomes (event / re-event). 10. the importance of body fat distribution and the intra-abdominal hepatic and intramuscular fat distribution pattern for cardiovascular risk. 11. the importance of stress-induced (test meal versus physical stress) metabolic (lipids, glucometabolites, amino acids, etc.) changes related to the new Event. 12. Changes of kidney function during follow-up - Incident chronic kidney disease (CKD) - Progression of CKD - New onset of end stage renal disease (ESRD) 13. Major adverse kidney events (MAKE), defined as a 25% reduction of eGFR or new onset of ESRD or death. 14. New onset of ESRD or 25% reduction of eGFR. 15. New or recurrent AKI episodes. 16. Relevance of peripheral neuropathy (measured by questionnaires, clinical as well as neurophysiological examination), neuropathic pain and autonomic neuropathy (measured by questionnaire and heart rate variability) in predicting microangiopathy (fundus photo | — |
Countries
Germany
Contacts
Public ContactKathrin Haubold
Berlin Institute of Health (BIH)
Outcome results
None listed