Stroke Arrhythmia Monitoring Database (SAMBA)
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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 |
- Prevalence of high grade cardiac arrhythmia after stroke [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
- 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 |
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:
- None
Contacts and Locations| Germany | |
| University Hospital Erlangen, Dept. of Neurology | |
| Erlangen, Bavaria, Germany, 91054 | |
| 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 May 23, 2013