StrokePacificNCT02180542
Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.
An observational study of Stroke and Atrial Fibrillation, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to improve secondary prevention of ischemic stroke patients by 1. Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Atrial Fibrillation, Premature Atrial Complexes
- How many people
- 264 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Oct 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ischemic stroke patients admitted to the hospital
Who may be able to join
- admitted with ischemic stroke at a single center
- time from diagnose to inclusion maximum 7 days.
- written informed consent or surrogate informed consent eligible
- age > 18 years.
Who cannot join
- hemorrhagic stroke
- terminal illness and expected lifespan of less than 6 months.
- any physical or mental condition which make the patients unsuitable for participation in the study.
- known with a pacemaker
- anticoagulation treatment of other reasons than atrial fibrillation.
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: Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke: Prevalence, Characteristics and Prognosis
The purpose of this study is to improve secondary prevention of ischemic stroke patients by
- Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.
- Characterize ischemic stroke patients by
- Echocardiographic characteristics
- Biochemical markers
- Plaque composition in the carotid arteries
- in order to improve risk stratification.
Read the detailed description
Patients with atrial fibrillation (AF) have a five-fold increased risk of ischemic stroke compared to the general population. Identifying AF can be challenging, but prolonged rhythm monitoring of ischemic stroke patients have shown to enhance detection rates of AF. Therefore it is important to identify predictors of AF to allow targeted screening of patients after ischemic stroke and thereby reduce the recurrent stroke rate. Few former studies have shown an association between excessive numbers of premature atrial complexes (PACs) and AF.
The study population of ischemic stroke patients will at admission undergo following examinations:
- ECG
- 48 hours inpatient cardiac telemetry (If not known AF)
- 24 hours holter monitoring (if not known AF)
- echocardiogram
- blood sample
- CT scan of carotid arteries with contrast made on Dual Energy CT scan.
In the follow-up period, patients will have two visits with 48 hour holter monitoring (after 6 and 12 months, respectively) It will be noticed if patients have any recurrent events, die og developing AF.
The study population will be divided into four groups as follows:
- patients with new AF at admission
- patients with known AF
- patients with frequent PACs
- patients without frequent PACs. These groups will be compared on baseline characteristics and on outcome as mentioned.
The overall perspective is to make better strategies for detecting occult AF after ischemic stroke to improve secondary stroke prevention care.
- Conditions
- Stroke, Atrial Fibrillation, Premature Atrial Complexes
- Keywords
- stroke, Ischemic stroke, Cerebral infarction, recurrent stroke, atrial fibrillation, premature atrial complexes, heart rhythm monitoring, left atrial function, carotid artery, plaque morphology
- Medical subject headings
- Stroke, Atrial Fibrillation, Atrial Premature Complexes, Ischemic Stroke, Cerebral Infarction
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 |
|---|---|---|
| Ischemic stroke patients | Patients admitted with ischemic stroke from march 2012 to april 2014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to death and recurrent stroke
Measured: Up to 4 years
Secondary outcomes (2)
Time to death, recurrent stroke and atrial fibrillation
Measured: Up to 4 years
Left atrial volume and function estimated by echocardiography
descriptive comparison in between groups.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Kristina Hoeg Vinther, Odense University Hospital
- Investigators
- Kristina H Vinther, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180542
- Sponsor's protocol ID
- Pacific
- Acronym
- Pacific
- Status last verified
- Oct 2017
- First submitted
- 1 Jul 2014
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke: Prevalence, Characteristics and Prognosis
- ClinicalTrials.gov ID
- NCT02180542
- Acronym / sponsor ID
- Pacific / Pacific
- Conditions
- Stroke, Atrial Fibrillation, Premature Atrial Complexes
- Keywords
- stroke, Ischemic stroke, Cerebral infarction, recurrent stroke, atrial fibrillation, premature atrial complexes, heart rhythm monitoring, left atrial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Jul 2014 (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 improve secondary prevention of ischemic stroke patients by
- Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.
- Characterize ischemic stroke patients by
- Echocardiographic characteristics
- Biochemical markers
- Plaque composition in the carotid arteries
- in order to improve risk stratification.
Detailed description
Patients with atrial fibrillation (AF) have a five-fold increased risk of ischemic stroke compared to the general population. Identifying AF can be challenging, but prolonged rhythm monitoring of ischemic stroke patients have shown to enhance detection rates of AF. Therefore it is important to identify predictors of AF to allow targeted screening of patients after ischemic stroke and thereby reduce the recurrent stroke rate. Few former studies have shown an association between excessive numbers of premature atrial complexes (PACs) and AF.
The study population of ischemic stroke patients will at admission undergo following examinations:
- ECG
- 48 hours inpatient cardiac telemetry (If not known AF)
- 24 hours holter monitoring (if not known AF)
- echocardiogram
- blood sample
- CT scan of carotid arteries with contrast made on Dual Energy CT scan.
In the follow-up period, patients will have two visits with 48 hour holter monitoring (after 6 and 12 months, respectively) It will be noticed if patients have any recurrent events, die og developing AF.
The study population will be divided into four groups as follows:
- patients with new AF at admission
- patients with known AF
- patients with frequent PACs
- patients without frequent PACs. These groups will be compared on baseline characteristics and on outcome as mentioned.
The overall perspective is to make better strategies for detecting occult AF after ischemic stroke to improve secondary stroke prevention care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke patients | – | –Patients admitted with ischemic stroke from march 2012 to april 2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients admitted to the hospital
Key inclusion criteria (4 listed)
- admitted with ischemic stroke at a single center
- time from diagnose to inclusion maximum 7 days.
- written informed consent or surrogate informed consent eligible
- age > 18 years.
Key exclusion criteria (5 listed)
- hemorrhagic stroke
- terminal illness and expected lifespan of less than 6 months.
- any physical or mental condition which make the patients unsuitable for participation in the study.
- known with a pacemaker
- anticoagulation treatment of other reasons than atrial fibrillation.
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 and recurrent stroke
Time frame: Up to 4 years
2 secondary outcomes
Time to death, recurrent stroke and atrial fibrillation
Time frame: Up to 4 years
Left atrial volume and function estimated by echocardiography
Time frame: baseline
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 11 Oct 2017.
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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 Stroke and 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 4 inclusion and 5 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 11 Oct 2017. 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 and 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 11 Oct 2017.