HEart and BRain Interfaces in Acute Ischemic Stroke

NCT02142413 | Completed DMC

• 1 other identifier: EA2/033/14
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Atrial Fibrillation

Keywords

Stroke; Atrial fibrillation; Holter ECG; cardiac MRI

Outcome Measures

Primary Outcomes (1)

• Stroke aetiology

  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 Outcomes (3)

• Atrial fibrillation

  up to 5 days after hospital discharge

• Stroke localization and cardiac dysfunction

  From admission to the stroke unit to hospital discharge, or up to 5 days during hospital stay

• Outcome

  day 90 and day 365 after stroke onset

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Center for Stroke Research Berlin: collaborator

Study Sites (1)

Charité, University Medicine Berlin

Berlin, 12200, Germany

Location

Related Publications (3)

• Hellwig S, Krause T, Scheitz JF, Herm J, Grittner U, Jauert N, Fiebach JB, Kasner M, Doehner W, Endres M, Wachter R, Elgeti T, Nolte CH, Haeusler KG. Enhanced diagnostic workup increases pathological findings in patients with acute ischaemic stroke: results of the prospective HEBRAS study. Stroke Vasc Neurol. 2024 Apr 30;9(2):145-152. doi: 10.1136/svn-2022-002179.

  PMID: 37353342 DERIVED

• von Rennenberg R, Herm J, Krause T, Hellwig S, Stengl H, Scheitz JF, Elgeti T, Nagel SN, Endres M, Haeusler KG, Nolte CH. Elevation of cardiac biomarkers in stroke is associated with pathological findings on cardiac MRI-results of the HEart and BRain interfaces in Acute Stroke study. Int J Stroke. 2023 Feb;18(2):180-186. doi: 10.1177/17474930221095698. Epub 2022 May 11.

  PMID: 35403503 DERIVED

• Haeusler KG, Grittner U, Fiebach JB, Endres M, Krause T, Nolte CH. HEart and BRain interfaces in Acute ischemic Stroke (HEBRAS)--rationale and design of a prospective oberservational cohort study. BMC Neurol. 2015 Oct 22;15:213. doi: 10.1186/s12883-015-0458-2.

  PMID: 26490042 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl G Häusler, MD; FESC

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Christian H Nolte, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

DE (1)