- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02142413
HEart and BRain Interfaces in Acute Ischemic Stroke (HEBRAS)
HEart and BRain Interfaces in Acute Ischemic Stroke (HEBRAS) - A Prospective Oberservational Cohort Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 12200
- Charité, University Medicine Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
From admission to the stroke unit to hospital discharge, or up to 5 days during hospital stay
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
From admission to the stroke unit to hospital discharge, or up to 5 days during hospital stay
|
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.
|
day 90 and day 365 after stroke onset
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christian H Nolte, MD, Charite University, Berlin, Germany
- Principal Investigator: Karl G Häusler, MD; FESC, Charite University, Berlin, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA2/033/14 (Ethics comission, Charité)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey