SYSTEMI - Systemic organ communication in STEMI: Design and rationale of a cohort study of patients with ST-segment elevation myocardial infarction

Abstract

AbstractBackground(335/350) ST-segment elevation myocardial infarction (STEMI) still causes significant mortality and morbidity despite best-practice revascularization and adjunct medical strategies. Within the STEMI population, there is a spectrum of higher and lower risk patients with respect to major adverse cardiovascular and cerebral events (MACCE) or re-hospitalization due to heart failure. Myocardial and systemic metabolic disorders modulate patient risk in STEMI. Systematic cardiocirculatory and metabolic phenotyping to assess the bidirectional interaction of cardiac and systemic metabolism in myocardial ischemia is lacking.MethodsSystemic organ communication in STEMI (SYSTEMI) is an all-comer open-end prospective study in STEMI patients >18 years of age to assess the interaction of cardiac and systemic metabolism in STEMI by systematically collecting data on a regional and systemic level. Primary endpoint will be myocardial function, left ventricular remodelling, myocardial texture and coronary patency at 6 month after STEMI. Secondary endpoint will be all-cause death, MACCE, and re-hospitalisation due to heart failure or revascularisation assessed 12 month after STEMI. The objective of SYSTEMI is to identify metabolic systemic and myocardial master switches that determine primary and secondary endpoints. In SYSTEMI 150-200 patients are expected to be recruited per year. Patient data will be collected at the index event, within 24 hours, 5 days as well as 6 and 12 months after STEMI. Data acquisition will be performed in multilayer approaches. Myocardial function will be assessed by using serial cardiac imaging with cineventriculography, echocardiography and cardiovascular magnetic resonance. Myocardial metabolism will be analysed by multi-nuclei magnetic resonance spectroscopy. Systemic metabolism will be approached by serial liquid biopsies and analysed with respect to glucose and lipid metabolism as well as oxygen transport. In summary, SYSTEMI enables a comprehensive data analysis on the levels of organ structure and function alongside hemodynamic, genomic and transcriptomic information to assess cardiac and systemic metabolism.DiscussionSYSTEMI aims to identify novel metabolic patterns and master-switches in the interaction of cardiac and systemic metabolism to improve diagnostic and therapeutic algorithms in myocardial ischemia for patient-risk assessment and tailored therapy.Trial registrationTrial Registration Number:NCT03539133;Registration Date29.05.2018Administrative informationNote: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (seehttp://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).Funding {4}This trial was supported by the German Research Foundation SFB 1116 Grant No. 236177352, as well as project grants BO 4264/1-1 (F.B.); the German Diabetes Center (DDZ), which is funded by the German Federal Ministry of Health and the Ministry of Culture and Science of the state North Rhine-Westphalia and from the German Federal Ministry of Education and Research (BMBF) to the German Center for Diabetes Research (DZD).Trialsstructured Study Protocol templateTrialsguidance: the numbers in curly brackets (e.g. {5a}) are SPIRIT item identifiers.Please do not remove the numbers in curly brackets, or any heading that contains them.The item identifiers are slightly out of sequence to make the document flow more easily but it is important that they remain in the document to allow electronic searches by SPIRIT item number.https://trialsjournal.biomedcentral.com/submission-guidelines/preparing-your-manuscript/study-protocoll