Acute Stroke Clinical Trial
— SAMBAVerified date | March 2012 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 501 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients treated on the stroke unit - Patients with telemetric monitoring Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Erlangen, Dept. of Neurology | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Germany,
Kallmünzer B, Breuer L, Hering C, Raaz-Schrauder D, Kollmar R, Huttner HB, Schwab S, Köhrmann M. A structured reading algorithm improves telemetric detection of atrial fibrillation after acute ischemic stroke. Stroke. 2012 Apr;43(4):994-9. doi: 10.1161/ST — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of high grade cardiac arrhythmia after stroke | 72 hours | Yes | |
Secondary | Detection of paroxysmal atrial fibrillation by different diagnostic approaches | 72 hours | No | |
Secondary | Cerebral lesion distribution in patients with cardiac arrhythmia | 72 hours | No | |
Secondary | Impact of arrhythmia on clinical outcome and mortality after 90 days | 90 days post stroke | No |
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