Ischemic StrokeNCT02610803
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
An observational study of Ischemic Stroke and Paroxysmal Atrial Fibrillation, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Paroxysmal Atrial Fibrillation, Premature Atrial Complexes
- How many people
- 863 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Oct 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 with acute ischemic stroke, admitted to our hospital between August 2008-April 2011
Who may be able to join
- admitted with ischemic stroke from August 2008-April 2011
- Registered in the Danish Stroke Registry
Who cannot join
- Hemorrhagic stroke
- No Danish civil registration
- no permanent address in Denmark during follow-up.
- patients with lack of telemetry data
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Research, OUH, Svendborg
Svendborg, Funen, 5700
About this study
Official title: Paroxysmal Atrial Fibrillation and Brief Runs of Premature Atrial Complexes in Patients With Acute Ischemic Stroke: A Historical Cohort Study
The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. Furthermore to evaluate the prognostic significance of brief runs of premature atrial complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic attack and death.
Read the detailed description
Stroke is the second leading cause of death worldwide and it is well known that atrial fibrillation(AF) is a major risk factor for ischemic stroke. Paroxysmal AF can be difficult to detect because many cases are asymptomatic. In recent years prolonged cardiac rhythm monitoring of patients with ischemic stroke has showed an underestimated prevalence of AF. However, no optimal monitoring strategy is implemented in the clinic yet. This is the reason why research currently is focused on finding predictive risk markers of AF. Cohort studies of healthy individuals and stroke patients have shown that excessive premature atrial complexes (PACs) and brief runs of PACs are an emerging risk marker in helping to identifying patients in risk of having or developing AF. Despite this brief runs of PACs less than 30 s are today in everyday clinical practice perceived to be of no clinical significance.
The study population of ischemic stroke patients have all without known AF underwent ECG and 48 hours' inpatient cardiac telemetry as a clinical routine. In the medical record it is registered if patients had runs of PACs or new diagnosed AF.
All patients are registered in the Danish Stroke Registry, and all the baseline data on patients will be obtained from the registry.
The follow-up end August 2015 and information on AF, recurrent stroke and death will be obtained from medical records and the Funen Patient Administrative System, which is linked to the national Civil Registration System.
The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of PACs and new diagnosed AF. Furthermore to evaluate the prognostic significance of brief runs of PACs in relation to develop AF and the prognostic significance of brief runs of PACs and AF in relation to recurrent stroke and death.
- Keywords
- stroke, ischemic stroke, recurrent stroke, atrial fibrillation, premature atrial complexes, heart rhythm monitoring, cardiac telemetry
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation, Atrial Premature Complexes, 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 |
|---|---|---|
| Patients with ischemic stroke | Patients admitted with ischemic stroke from August 2008 to April 2011 (Retrospectively defined). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death or recurrent stroke
Measured: Up to 4 years
Secondary outcomes (4)
Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry
Measured: up to 2 days
Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry
Measured: up to 2 days
Time to develop atrial fibrillation in patients without know atrial fibrillation at admission. Registered in Medical journals and discharge letters.
Measured: Up to 4 years
Number of patients with atrial fibrillation having oral anticoagulant treatment at discharge. Data will be extracted from the Danish Stroke Registry.
Measured: to the day of discharge (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 863 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Hoeg Vinther, Odense University Hospital
- Investigators
- Kristina H Vinther, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610803
- Sponsor's protocol ID
- HISPACs
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxysmal Atrial Fibrillation and Brief Runs of Premature Atrial Complexes in Patients With Acute Ischemic Stroke: A Historical Cohort Study
- ClinicalTrials.gov ID
- NCT02610803
- Acronym / sponsor ID
- HISPACs
- Keywords
- stroke, ischemic stroke, recurrent stroke, atrial fibrillation, premature atrial complexes, heart rhythm monitoring, cardiac telemetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 863 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Nov 2015 (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.
The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. Furthermore to evaluate the prognostic significance of brief runs of premature atrial complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic attack and death.
Detailed description
Stroke is the second leading cause of death worldwide and it is well known that atrial fibrillation(AF) is a major risk factor for ischemic stroke. Paroxysmal AF can be difficult to detect because many cases are asymptomatic. In recent years prolonged cardiac rhythm monitoring of patients with ischemic stroke has showed an underestimated prevalence of AF. However, no optimal monitoring strategy is implemented in the clinic yet. This is the reason why research currently is focused on finding predictive risk markers of AF. Cohort studies of healthy individuals and stroke patients have shown that excessive premature atrial complexes (PACs) and brief runs of PACs are an emerging risk marker in helping to identifying patients in risk of having or developing AF. Despite this brief runs of PACs less than 30 s are today in everyday clinical practice perceived to be of no clinical significance.
The study population of ischemic stroke patients have all without known AF underwent ECG and 48 hours' inpatient cardiac telemetry as a clinical routine. In the medical record it is registered if patients had runs of PACs or new diagnosed AF.
All patients are registered in the Danish Stroke Registry, and all the baseline data on patients will be obtained from the registry.
The follow-up end August 2015 and information on AF, recurrent stroke and death will be obtained from medical records and the Funen Patient Administrative System, which is linked to the national Civil Registration System.
The purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of PACs and new diagnosed AF. Furthermore to evaluate the prognostic significance of brief runs of PACs in relation to develop AF and the prognostic significance of brief runs of PACs and AF in relation to recurrent stroke and death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ischemic stroke | – | –Patients admitted with ischemic stroke from August 2008 to April 2011 (Retrospectively defined). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke, admitted to our hospital between August 2008-April 2011
Key inclusion criteria (2 listed)
- admitted with ischemic stroke from August 2008-April 2011
- Registered in the Danish Stroke Registry
Key exclusion criteria (4 listed)
- Hemorrhagic stroke
- No Danish civil registration
- no permanent address in Denmark during follow-up.
- patients with lack of telemetry data
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
Time to death or recurrent stroke
Time frame: Up to 4 years
4 secondary outcomes
Number of patients diagnosed with atrial fibrillation by 48 hours' continuous inpatient cardiac telemetry
Time frame: up to 2 days
Number of patients diagnosed with runs of premature atrial complexes by 48 hours' continuous cardiac telemetry
Time frame: up to 2 days
Time to develop atrial fibrillation in patients without know atrial fibrillation at admission. Registered in Medical journals and discharge letters.
Time frame: Up to 4 years
Number of patients with atrial fibrillation having oral anticoagulant treatment at discharge. Data will be extracted from the Danish Stroke Registry.
Time frame: to the day of discharge (up to 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
Kristina H Vinther, MD principal investigator
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 Ischemic Stroke and Paroxysmal Atrial Fibrillation, run by Odense University Hospital at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 20 Nov 2015. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to death or recurrent stroke (time frame: Up to 4 years). 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 20 Nov 2015.