Stroke Arrhythmia Monitoring Database (SAMBA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Köhrmann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01177748
First received: August 5, 2010
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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
Acute Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Prevalence of high grade cardiac arrhythmia after stroke [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Detection of paroxysmal atrial fibrillation by different diagnostic approaches [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Cerebral lesion distribution in patients with cardiac arrhythmia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Impact of arrhythmia on clinical outcome and mortality after 90 days [ Time Frame: 90 days post stroke ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients on the Stroke Unit

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering from acute cerebral injury treated on a specialized Stroke Unit

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177748

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Köhrmann, MD, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01177748     History of Changes
Other Study ID Numbers: DE-ER-SAMBA
Study First Received: August 5, 2010
Last Updated: March 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:
Stroke
Cardiac Monitoring

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014