Assessment of relationship between acute ischemic stroke and heart disease--protocol of a prospective observational trial.

Background: Stroke and acute myocardial infarction are the leading causes of death and disability in industrialized countries. Multiple interactions exist between the various forms of cardiovascular and cerebrovascular diseases, and risk factors for development of stroke and major cardiovascular events are similar. There is currently no clear link between acute coronary syndrome and stroke, although it has been repeatedly described. In addition, there are currently no clear recommendations for how to proceed in the case of signs of myocardial damage in patients with acute stroke and how to manage the next follow-up. METHODS-DESIGN: In this prospective observational trial, 500 consecutive ischemic stroke patients admitted at the Comprehensive Stroke Center will be enrolled within 12 h from stroke onset. The set of examinations will consist of: 1) Acute brain computed tomography or magnetic resonance imaging 2) Laboratory tests: A) within 12 h from stroke onset: NT pro B-type of natriuretic peptide, pro-atrial natriuretic peptide, creatinekinase MB, troponin T (cTnT), interleukin 6, procalcitonin, high sensitive C-reactive protein and D-dimers. B) control level of cTnT after 4 h from admission C) non-acute laboratory samples within 60 h from stroke onset: glycated haemoglobine, serum lipids; 3) Electrocardiogram (ECG) on admission and 4 h from stroke onset; 4) Transesophageal or transthoracal echocardiography and 24-h ECG-Holter within 15 days from stroke onset; 5) Neurosonological examination within 60 h from stroke onset; 6) Thirty patients with a positive finding of acute myocardial ischemia (ECG, cTnT) will be examined by coronary angiography (CAG); 7) Epidemiological data will be acquired.

Statistics: The epidemiological characteristics of the whole sample of patients; correlation between differences between group of cardioembolic ischemic stroke patients and group of patients with ischemic stroke of another etiology; correlation of infarction volume on DWI-MRI with the level of cTnT; correlation of the ECG findings with the level of cTnT and clinical signs; correlation of the CAG findings with level of cTnT and ECG findings will be statistically evaluated at the 5% level of statistical significance.

Conclusion: The main goal of the project is to improve identification of patients with acute coronary syndrome and with concurrent acute ischemic stroke as these patients require specific treatment and secondary prevention of ischemic events.

Trial Registration: Clinicaltrials.gov NCT01541163.