Atrial FibrillationSCARFNCT01550042
Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients
An observational study of Atrial Fibrillation and Stroke, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with a ischemic stroke of undetermined etiology
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medisch Spectrum Twente / Thoraxcenter
Enschede, Overijssel, NL7513ER
About this study
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.
- Conditions
- Atrial Fibrillation, Stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (2)
Time to documented AF
Time to documented AF using an Implantable Loop Recorder (ILR) data
Measured: One year
Recurrent stroke
Incidence of recurrent stroke
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Inclusion rate problems, not enough eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B. Oude Velthuis, Medisch Spectrum Twente
- Investigators
- Marcoen Scholten, MD PhD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550042
- Sponsor's protocol ID
- NL36491.044.11
- Other IDs
- P11-25
- Acronym
- SCARF
- Status last verified
- Nov 2024
- First submitted
- 7 Mar 2012
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients
- ClinicalTrials.gov ID
- NCT01550042
- Acronym / sponsor ID
- SCARF / NL36491.044.11
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion rate problems, not enough eligible patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with a ischemic stroke of undetermined etiology
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Documented Atrial Fibrillation (AF)
Time frame: One year
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.
2 secondary outcomes
Time to documented AF
Time frame: One year
Recurrent stroke
Time frame: One year
Results and safety
The study was stopped early (reason given: Inclusion rate problems, not enough eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- ThoraxcenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcoen Scholten, MD PhD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion rate problems, not enough eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented Atrial Fibrillation (AF) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.