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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
Sponsor:
Collaborator:
Center for Stroke Research Berlin
Information provided by (Responsible Party):
Karl Georg Haeusler, Charite University, Berlin, Germany

Brief Summary:
The primary aim of this prospective observational study is to investigate whether an enhanced diagnostic MRI work-up (including cardiac MRI, angiography of the aortic arch and the brain-supplying arteries) combined with an in-hospital Holter-ECG of up to 5 days duration leads to a significant increase in relevant pathologic findings with respect to stroke aetiology as compared to the findings obtained by a routine diagnostic work-up (including stroke unit monitoring, 24h-Holter-ECG, echocardiography, Doppler-ultrasound of the brain-supplying arteries) in patients with acute ischemic stroke and no atrial fibrillation according to past medical history or baseline ECG. A better understanding of the stroke aetiology may improve secondary stroke prevention and long term outcome.

Condition or disease
Stroke Atrial Fibrillation

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 368 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Biomarkers indicating myocardial damage (cardiac Troponin T), autonomic function (Norepinephrine), prediction of atrial fibrillation (BNP).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the specialized stroke unit at the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF), due to an acute ischemic stroke.
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Written informed consent by the patient
  • Acute ischemic stroke, as confirmed by cerebral MRI or CT
  • Admission to the stroke unit of the Department of Neurology, Charité, Campus Benjamin Franklin

Exclusion Criteria:

  • Atrial fibrillation known by past medical history or documented by routine electrocardiogram (ECG) on hospital admission
  • Participation in an interventional clinical trial
  • Pre-stroke life expectancy <1 year
  • Mechanic heart valve, cardiac pacemaker or other contraindications to undergo MRI
  • History of adverse response to MRI contrast agents
  • Known Liver disease prior to stroke
  • Mild to severe renal dysfunction (creatinine > 1.3 mg/dl (females); creatinine > 1,7 mg/dl (males))
  • Severe congestive heart failure (NYHA III or IV).

Information from the National Library of Medicine

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


Locations
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Germany
Charité, University Medicine Berlin
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Center for Stroke Research Berlin
Investigators
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Principal Investigator: Karl G Häusler, MD; FESC Charite University, Berlin, Germany
Principal Investigator: Christian H Nolte, MD Charite University, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karl Georg Haeusler, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02142413     History of Changes
Other Study ID Numbers: EA2/033/14
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Keywords provided by Karl Georg Haeusler, Charite University, Berlin, Germany:
Stroke
Atrial fibrillation
Holter ECG
cardiac MRI

Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes