Atrial FibrillationFinCV-4NCT04001205
Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
An observational study of Atrial Fibrillation and Stroke, Ischemic, run by University of Turku at 1 site in Finland.
Trial summary
This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke, Ischemic
- What is being tested?
- Anticoagulation Therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 1,300 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2019to 8 Jan 2025
- 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: Original FinCV study (Airaksinen et al. JACC 2013) eligibility criteria: All patients with a primary diagnosis of atrial fibrillation (ICD-10 code I48) were identified from the institutional discharge registries in the 3 participating hospitals. Emergency clinic admission records and databases were then used to review all patients (>18 years of age) with acute (<48 h) atrial fibrillation who underwent cardioversion during the study period. In addition, only patients living in the hospital catchment area were included to get the adequate follow-up data after the cardioversion.
- primary diagnosis of atrial fibrillation (ICD-10 code I48)
- Cardioversion for acute (<48 h) atrial fibrillation
- >18 years of age
- living within the catchment area of the hospital
Trial locations and contacts
1 site in 1 country.
Finland1 site
Turku University Hospital, Heart Center
Turku, Southwest Finland, 20521
About this study
Official title: Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.
Read the detailed description
The study population consists of the FinCV-dataset, which includes 7660 acute cardioversions for atrial fibrillation. The electronic patient records of FinCV-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. We seek to explore the possible association between the frequency of AF paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. Data collection is performed by reviewing electronic patient records.
- Conditions
- Atrial Fibrillation, Stroke, Ischemic
- Being tested
- Anticoagulation Therapy
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation TherapyDrug
Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)
| Study group | Role | What they receive |
|---|---|---|
| No oral anticoagulation | Patients without oral anticoagulation for AF | |
| Oral anticoagulation | Patients with long term oral anticoagulation Receives: Drug: Anticoagulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from any cause
Measured: From the first cardioversion through study completion, an average of 6 years
Ischemic stroke or TIA (transient ischemic attack)
Ischemic stroke or TIA diagnosed by neurologist
Measured: From the first cardioversion through study completion, an average of 6 years
Major Bleed
Major Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis)
Measured: From the first cardioversion through study completion, an average of 6 years
Secondary outcomes (1)
Permanent oral anticoagulation
Initiation of permanent oral anticoagulation therapy, information on oral anticoaglation initiation done by reviewing electronic patient records
Measured: From the first cardioversion through study completion, an average of 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Jun 2019
- Primary completion8 Jan 2025 (estimated)
- Study completion8 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Airaksinen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001205
- Sponsor's protocol ID
- T75/2019
- Acronym
- FinCV-4
- Status last verified
- May 2024
- First submitted
- 21 Jun 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.
PubMed 23850908
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study
- ClinicalTrials.gov ID
- NCT04001205
- Acronym / sponsor ID
- FinCV-4 / T75/2019
- Conditions
- Atrial Fibrillation, Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 8 Jan 2025 (estimated)
- Study completion
- 8 Jan 2025 (estimated)
- First posted
- 27 Jun 2019 (actual)
- 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.
This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.
Detailed description
The study population consists of the FinCV-dataset, which includes 7660 acute cardioversions for atrial fibrillation. The electronic patient records of FinCV-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. We seek to explore the possible association between the frequency of AF paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. Data collection is performed by reviewing electronic patient records.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No oral anticoagulation | – | –Patients without oral anticoagulation for AF |
| Oral anticoagulation | – | Drug: Anticoagulation TherapyPatients with long term oral anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Original FinCV study (Airaksinen et al. JACC 2013) eligibility criteria: All patients with a primary diagnosis of atrial fibrillation (ICD-10 code I48) were identified from the institutional discharge registries in the 3 participating hospitals. Emergency clinic admission records and databases were then used to review all patients (>18 years of age) with acute (<48 h) atrial fibrillation who underwent cardioversion during the study period. In addition, only patients living in the hospital catchment area were included to get the adequate follow-up data after the cardioversion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulation TherapyLong term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant) | Drug | Oral anticoagulation |
Primary outcome
Death
Time frame: From the first cardioversion through study completion, an average of 6 years
Death from any cause
Ischemic stroke or TIA (transient ischemic attack)
Time frame: From the first cardioversion through study completion, an average of 6 years
Ischemic stroke or TIA diagnosed by neurologist
Major Bleed
Time frame: From the first cardioversion through study completion, an average of 6 years
Major Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis)
1 secondary outcome
Permanent oral anticoagulation
Time frame: From the first cardioversion through study completion, an average of 6 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 23850908Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.
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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.
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, Ischemic, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 May 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 Finland. 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?
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?
Death (time frame: From the first cardioversion through study completion, an average of 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001205, which also lists 1 linked publication.
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 8 May 2024.