Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 8, 2020
Date Accepted: Dec 15, 2020
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Cardiomyocyte injury following Acute Ischemic Stroke (CORONA-IS): Protocol for a prospective observational cohort study
ABSTRACT
Background:
Elevated cardiac troponin (cTn) indicating cardiomyocyte injury is common after acute ischemic stroke (AIS) and associated with poor functional outcome. Myocardial injury is part of a broad spectrum of cardiac complications that may occur after AIS. Previous studies have shown that in most patients the underlying mechanism of stroke-associated myocardial injury may not be a concomitant acute coronary syndrome. Evidence from animal research, clinical and neuroimaging studies suggest that functional and structural alterations in the central autonomic network leading to stress-mediated neurocardiogenic injury may be a key underlying mechanism (i.e., ‘Stroke-Heart-Syndrome’). However, the exact pathophysiological cascade remains unclear and diagnostic and therapeutic implications are unknown.
Objective:
The aim of the Cardiomyocyte injury following Acute Ischemic Stroke (CORONA-IS) study is to quantify autonomic dysfunction and to decipher downstream cardiac mechanisms leading to myocardial injury after AIS.
Methods:
In this prospective, observational, single-center cohort study, 300 patients with acute ischemic stroke, confirmed via cerebral MRI and presenting within 48h of symptom onset, will be recruited during in-hospital stay. Based on high-sensitivity cardiac troponin levels (hs troponinT, Gen. V, Roche Elecsys®) and corresponding to the fourth universal definition of myocardial infarction, three groups are defined (i.e. ‘no myocardial injury’ [no cTN elevation], ‘chronic myocardial injury’ [stable elevation] and ‘acute myocardial injury’ [dynamic rise/fall pattern]). Each group will include approximately 100 patients. Study patients will receive routine diagnostic care and additionally, 1) 3T cardiovascular MRI and transthoracic echocardiography within 5 days of symptom onset to provide myocardial tissue characterization and assess cardiac function, 2) 20-minute high-resolution ECG-recording for analysis of cardiac autonomic function, and 3) extensive biobanking. A follow-up for cardiovascular events will be conducted 3 and 12 months after inclusion.
Results:
After a four-month pilot phase, recruitment started in April 2019. We estimate a recruitment period of approximately three years to include 300 patients with complete CMR protocol.
Conclusions:
Stroke-associated myocardial injury is a common and relevant complication. Our study has the potential to provide a better mechanistic understanding of heart and brain interaction in the setting of acute stroke. This will be essential to develop algorithms for recognizing patients at risk and refine diagnostic and therapeutic procedures. Clinical Trial: Clinicaltrials.gov NCT03892226
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