Stroke Arrhythmia Monitoring Database (SAMBA)

March 30, 2012 updated by: Martin Köhrmann, University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University Hospital Erlangen, Dept. of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients on the Stroke Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of high grade cardiac arrhythmia after stroke
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of paroxysmal atrial fibrillation by different diagnostic approaches
Time Frame: 72 hours
72 hours
Cerebral lesion distribution in patients with cardiac arrhythmia
Time Frame: 72 hours
72 hours
Impact of arrhythmia on clinical outcome and mortality after 90 days
Time Frame: 90 days post stroke
90 days post stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Martin Köhrmann, MD, Universityhospital Erlangen; Dept. of Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE-ER-SAMBA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe