Stroke Arrhythmia Monitoring Database | NCT01177748

Studies
Stroke Arrhythmia Monitoring Database

NCT01177748

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Apr 2, 2012Estimated

Enrollment

501Actual

Phase

Not provided

Conditions

Acute Stroke

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Aug 5, 2010

First Submission Date that Met QC Criteria

Aug 6, 2010

First Posted Date

Aug 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2012

Last Update Posted Date

Apr 2, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Köhrmann, MD, University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

501Actual

Label	Type	Description	Intervention Names
Patients on the Stroke Unit

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Detection of paroxysmal atrial fibrillation by different diagnostic approaches		72 hours
Cerebral lesion distribution in patients with cardiac arrhythmia		72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated on the stroke unit
Patients with telemetric monitoring

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Köhrmann, MD	Universityhospital Erlangen; Dept. of Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Erlangen, Dept. of Neurology		Erlangen	Bavaria	91054	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22308240	Result	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.
22961962	Derived

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases