Stroke Arrhythmia Monitoring Database (SAMBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01177748
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : April 2, 2012
Information provided by (Responsible Party):
Martin Köhrmann, University of Erlangen-Nürnberg Medical School

Brief Summary:

Cardiac arrhythmia are frequently observed after stroke. They may on one hand be causative for the stroke mainly in case of atrial fibrillation but on the other hand present severe complications of the stroke. In addition, cardiac comorbidity as well as acute myocardial infarction are frequently found in acute stroke patients. Diagnostics to identify cardiac arrhythmia in the acute phase of stroke care thus have an important role not only for adjusting the correct secondary prevention but also to prevent cardiac complications potentially reducing morbidity and mortality.

The aim of the SAMBA-Study is to systematically assess the prevalence of higher grade arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the first days after stroke onset. In addition, it evaluates different strategies to identify paroxysmal atrial fibrillation.

Condition or disease
Acute Stroke

Study Type : Observational
Actual Enrollment : 501 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Patients on the Stroke Unit

Primary Outcome Measures :
  1. Prevalence of high grade cardiac arrhythmia after stroke [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Detection of paroxysmal atrial fibrillation by different diagnostic approaches [ Time Frame: 72 hours ]
  2. Cerebral lesion distribution in patients with cardiac arrhythmia [ Time Frame: 72 hours ]
  3. Impact of arrhythmia on clinical outcome and mortality after 90 days [ Time Frame: 90 days post stroke ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from acute cerebral injury treated on a specialized Stroke Unit

Inclusion Criteria:

  • Patients treated on the stroke unit
  • Patients with telemetric monitoring

Exclusion Criteria:

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 identifier (NCT number): NCT01177748

University Hospital Erlangen, Dept. of Neurology
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Principal Investigator: Martin Köhrmann, MD Universityhospital Erlangen; Dept. of Neurology

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Martin Köhrmann, MD, University of Erlangen-Nürnberg Medical School Identifier: NCT01177748     History of Changes
Other Study ID Numbers: DE-ER-SAMBA
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by Martin Köhrmann, University of Erlangen-Nürnberg Medical School:
Cardiac Monitoring

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases