Finding Atrial Fibrillation in Patients With Unexplained... | NCT01498146

Studies
Finding Atrial Fibrillation in Patients With Unexplained Stroke Using Longterm Cardiac Monitoring

NCT01498146

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Jan 28, 2021Actual

Enrollment

85Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Denmark

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

Jan 2021

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

Apr 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Dec 21, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 23, 2011Estimated

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

Jan 26, 2021

Last Update Posted Date

Jan 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanne Christensen, Associate Research Professor, Consultant neurologist, Bispebjerg HospitalPrincipal Investigator

Lead Sponsor

Bispebjerg HospitalOTHER

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

The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous unexplained stroke. It uses long term monitoring of the heart of up to three years, searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.

Detailed Description

The SURPRISE study investigates the patients with cryptogenic stroke or transient ischemic attack (TIA), monitoring them with a cardiac loop recorder for up to three years.

it aims at estimating the amount of paroxysmal atrial fibrillation within our population of cryptogenic stroke patients.

Standard workup for a stroke patient does offer cardiac evaluation, but monitoring is limited to the time admitted, often just a few days.

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

85Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic stroke or TIA;
> 18 years of age,
the ability to provide a written consent

Exclusion Criteria:

prior or known AFIB
AF found during work up including 24 hour telemetric monitoring.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

the patients are included from the investigators stroke unit and day clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanne Christensen, MD, PhD, DMSci	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital, University Hospital of Copenhagen, dept of Neurology		Copenhagen		DK-2400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24726253	Derived	Biering-Sorensen T, Christensen LM, Krieger DW, Mogelvang R, Jensen JS, Hojberg S, Host N, Karlsen FM, Christensen H. LA emptying fraction improves diagnosis of paroxysmal AF after cryptogenic ischemic stroke: results from the SURPRISE study. JACC Cardiovasc Imaging. 2014 Sep;7(9):962-3. doi: 10.1016/j.jcmg.2014.02.003. Epub 2014 Apr 9. No abstract available.

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke
D001281	Atrial Fibrillation

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