Stroke Arrhythmia Monitoring Database

Acute Stroke Clinical Trial

— SAMBA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177748
• Other study ID #: DE-ER-SAMBA
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: March 30, 2012
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified 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

Clinical Trial 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.

Recruitment information / eligibility

• 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke

Locations

Country	Name	City	State
Germany	University Hospital Erlangen, Dept. of Neurology	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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

External Links

•   Universityhospital Erlangen, Dept. of Neurology