HEart and BRain Interfaces in Acute Ischemic Stroke (HEBRAS)
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|ClinicalTrials.gov Identifier: NCT02142413|
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : July 18, 2018
|Condition or disease|
|Stroke Atrial Fibrillation|
Variations and delays in the diagnostic procedures during hospitalization after acute ischemic stroke are still common, and at the same time, stroke aetiology remains cryptogenic in about 20-25% of stroke unit patients. Recent studies have shown that (a) cardiac MRI is now able to detect cardiac sources of embolism (thrombi and aortic plaques) with equal sensitivity as compared to echocardiography, and (b) prolonged ECG monitoring up to several days/weeks/years can significantly increase the detection rate of atrial fibrillation. These developments might allow a faster and more effective diagnostic work-up in patients with acute ischemic stroke compared to standard diagnostic procedures including doppler-ultrasound of the extracranial brain-supplying arteries, echocardiography, 24-h-Holter ECG and stroke unit monitoring. This prospective observational trial therefore aims to assess the detection rate of pathologic findings relevant to stroke aetiology as obtained by an enhanced MRI set-up (including cardiac MRI, MR-angiography of the brain-supplying arteries) and a prolonged Holter-ECG (of up to 5 days after the stroke) in comparison to findings obtained by routine diagnostic procedures after acute stroke.
Moreover, cumulating evidence implies that acute ischemic stroke can lead to cardiac damage. Since the underlying pathophysiological mechanisms are still poorly understood, the HEBRAS study attempts to tackle the relationship between stroke localization (e.g. insular involvement), observed cardiac damage (as indicated by troponin elevation) and activation of autonomic nervous system (as indicated by impairment of heart rate variability and elevated urinary norepinephrine levels), respectively.
Finally, to clarify the prognostic impact of stroke-induced autonomic dysfunction, heart rate variability will be analysed with respect to functional outcome, mortality, recurrent stroke and myocardial injury.
|Study Type :||Observational|
|Actual Enrollment :||368 participants|
|Official Title:||HEart and BRain Interfaces in Acute Ischemic Stroke (HEBRAS) - A Prospective Oberservational Cohort Study|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||March 2018|
Acute Ischemic Stroke
Patients older than 18 years with an acute ischemic stroke (according to WHO criteria), stroke onset within 2 days, language: German, MRI compatibility, admission to the stroke unit at the Charité, Campus Benjamin Franklin.
- Stroke aetiology [ Time Frame: From admission to the stroke unit to hospital discharge, or up to 5 days during hospital stay ]Detection rate of pathologic findings relevant to stroke aetiology (i.e. atrial fibrillation, cardiac thrombi, severe carotid stenosis, aortic plaque > 4mm) in patients with acute ischemic stroke obtained by enhanced diagnostic MRI work-up (cardiac MRI, MR-angiography combined with prolonged Holter-ECG of up to 5 days during the in-hospital stay) in comparison to findings obtained by the routine diagnostic work-up at the Department of Neurology; Charité, Campus Benjamin Franklin (consisting of stroke unit monitoring, echocardiography, ultrasound of the brain-supplying arteries, and 24-hour Holter-ECG).
- Atrial fibrillation [ Time Frame: up to 5 days after hospital discharge ]Rate of first detected paroxysmal atrial fibrillation by prolonged Holter-ECG monitoring (up to 5 days) after hospital discharge.
- Stroke localization and cardiac dysfunction [ Time Frame: From admission to the stroke unit to hospital discharge, or up to 5 days during hospital stay ]Association of stroke localization (e.g. insular cortex involvement) to autonomic changes (as indicated by elevated urinary norepinephrine levels and heart rate variability) or cardiac dysfunction (as indicated by troponin T serum levels), respectively.
- Outcome [ Time Frame: day 90 and day 365 after stroke onset ]Association of heart rate variability to poor functional outcome (mRS>2) and mortality at day 90, as well as to the combined endpoint of recurrent ischemic stroke and myocardial infarction or death at day 365.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142413
|Charité, University Medicine Berlin|
|Berlin, Germany, 12200|
|Principal Investigator:||Karl G Häusler, MD; FESC||Charite University, Berlin, Germany|
|Principal Investigator:||Christian H Nolte, MD||Charite University, Berlin, Germany|