DeathPOAFNCT02349269
Postoperative Atrial Fibrillation and Long-term Survival
An observational study of Death and Stroke, run by Kuopio University Hospital.
Trial summary
The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Death, Stroke, Myocardial Infarction
- How many people
- 519 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2014
- How long will I take part?
- 105 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously
Who may be able to join
- previously cardiac operation, CABG or AVR
Who cannot join
- Previous Atrial fibrillation
About this study
Official title: Postoperative Atrial Fibrillation After Cardiac Surgery is Not an Independent Risk Factor for Long-term Cardiovascular Morbidity and Mortality in Anticoagulated Patients
The aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.
Read the detailed description
The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances.
Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.
- Conditions
- Death, Stroke, Myocardial Infarction
- Keywords
- Atrial fibrillation, CABG, Stroke
- Medical subject headings
- Death, Stroke, Myocardial Infarction, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular and all-cause death
Measured: 1-105 month
stroke
Measured: 1-105 month
late atrial fibrillation
Measured: 1-105 month
myocardial infarction
Measured: 1-105 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies 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
- Enrolment
- 519 participants (actual)
- Target duration
- 105 Months
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349269
- Sponsor's protocol ID
- samuelm1
- Acronym
- POAF
- Status last verified
- Nov 2014
- First submitted
- 1 Dec 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Atrial Fibrillation After Cardiac Surgery is Not an Independent Risk Factor for Long-term Cardiovascular Morbidity and Mortality in Anticoagulated Patients
- ClinicalTrials.gov ID
- NCT02349269
- Acronym / sponsor ID
- POAF / samuelm1
- Conditions
- Death, Stroke, Myocardial Infarction
- Keywords
- Atrial fibrillation, CABG, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jan 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 aim of the investigators trial was to evaluate association between new onset postoperative atrial fibrillation (POAF) and late cardiovascular morbidity and mortality.
Detailed description
The material of this retrospective study consist patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously . A total of 519 consecutive patients underwent coronary artery bypass surgery, aortic valve replacement or combined aortic valve with coronary bypass surgery in Kuopio University Hospital from 2004 to 2008. Patients with previous episodes of atrial fibrillation (AF) or flutter and also patients with mitral valve surgery were excluded. All patients had continuous postoperative ECG monitoring for at least 48 hours. AF episodes lasting longer than 5 minutes were registered. Thereafter 12 lead ECG was recorded daily and in case of symptoms of rhythm disturbances.
Medical records were reviewed during 2012 using standardized data collection protocol. Statistics Finland database was used for mortality data.
Study design
- Target follow-up
- 105 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients without preoperative history of atrial fibrillation, participated in three different randomized controlled trials previously
Key inclusion criteria (1 listed)
- previously cardiac operation, CABG or AVR
Key exclusion criteria (1 listed)
- Previous 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
cardiovascular and all-cause death
Time frame: 1-105 month
stroke
Time frame: 1-105 month
late atrial fibrillation
Time frame: 1-105 month
myocardial infarction
Time frame: 1-105 month
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 28 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Stroke, run by Kuopio University Hospital.
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 1 inclusion and 1 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 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
cardiovascular and all-cause death (time frame: 1-105 month). The study lists 4 primary outcomes in all. 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 28 Jan 2015.