Extended Rhythm SCreening for AtRial Fibrillation in Cryp... | NCT01550042

Studies
Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

NCT01550042

Sponsor

Medisch Spectrum Twente

Status

Terminated

Last Update Posted

Nov 22, 2024Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Stroke

Interventions

Not provided

Countries

Netherlands

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

ID	Type	Description	Link
P11-25	Other Identifier	METC Twente

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inclusion rate problems, not enough eligible patients

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Mar 7, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 9, 2012Estimated

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

Nov 20, 2024

Last Update Posted Date

Nov 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Recent studies demonstrated that prolonged rhythm observation increases the detection of atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial fibrillation in these patients has important therapeutic implications for the anticoagulation regimen. However, data on optimal monitoring duration and method of AF detection are limited.

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive observation cohort		Patients > 18 years of age diagnosed with a recent episode of cryptogenic stroke with long term rhythm observation using an implantable loop recorder for detecting atrial fibrillation.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Documented Atrial Fibrillation (AF)	The percentage of patients with documented AF based on implantable cardiac monitor registration during a follow-up period of at least 12 months after an episode of cryptogenic stroke.	One year

Secondary Outcomes

Measure	Description	Time Frame
Time to documented AF	Time to documented AF using an Implantable Loop Recorder (ILR) data	One year
Recurrent stroke	Incidence of recurrent stroke

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > 18 years of age Recent episode (≤60 days) of cryptogenic ischemic stroke
Undetermined etiology with negative evaluation (including cardioembolism work- up) according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST)
Implantation of an implantable loop recorder within two months after index event
Able of providing informed consent

Exclusion Criteria:

Pre-existing indication for vitamin K antagonist
Untreated hyperthyroidism
Indication for pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT)
Severe co-morbidity not likely to complete follow-up for one year

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 admitted with a ischemic stroke of undetermined etiology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcoen Scholten, MD PhD	Medisch Spectrum Twente	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medisch Spectrum Twente / Thoraxcenter		Enschede	Overijssel	NL7513ER	Netherlands

Label	URL
Thoraxcenter	View source

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D020521	Stroke

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided