NCT01177748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

August 5, 2010

Last Update Submit

March 30, 2012

Conditions

Keywords

StrokeCardiac Monitoring

Outcome Measures

Primary Outcomes (1)

  • Prevalence of high grade cardiac arrhythmia after stroke

    72 hours

Secondary Outcomes (3)

  • Detection of paroxysmal atrial fibrillation by different diagnostic approaches

    72 hours

  • Cerebral lesion distribution in patients with cardiac arrhythmia

    72 hours

  • Impact of arrhythmia on clinical outcome and mortality after 90 days

    90 days post stroke

Study Arms (1)

Patients on the Stroke Unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen, Dept. of Neurology

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (2)

  • Kallmunzer B, Breuer L, Hering C, Raaz-Schrauder D, Kollmar R, Huttner HB, Schwab S, Kohrmann 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/STROKEAHA.111.642199. Epub 2012 Feb 2.

  • Kallmunzer B, Breuer L, Kahl N, Bobinger T, Raaz-Schrauder D, Huttner HB, Schwab S, Kohrmann M. Serious cardiac arrhythmias after stroke: incidence, time course, and predictors--a systematic, prospective analysis. Stroke. 2012 Nov;43(11):2892-7. doi: 10.1161/STROKEAHA.112.664318. Epub 2012 Sep 6.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Köhrmann, MD

    Universityhospital Erlangen; Dept. of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 9, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations