Atrial FibrillationCAREBANKNCT03444259
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by University of Turku at 1 site in Finland.
Trial summary
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,001 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2016to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Consecutive patients undergoing open-heart cardiac surgery
Who may be able to join
- Any open-heart cardiac surgery
- Written informed consent
- All-comers design
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role of inflammation in atrial fibrillation.
Read the detailed description
The investigators aim to A) compare atrial cardiomyopathy findings from the tissue samples to clinical phenotype and adverse events B) study the association of genetic defects predisposing to atrial fibrillation with atrial cardiomyopathy findings in the tissue samples C) assess the role of inflammation in atrial fibrillation by comparing circulating cytokine profiles, purinergic signaling and atrial cardiomyopathy findings in tissue samples.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease, Mitral Valve Disease, Cardiac Arrythmias
- Being tested
- Cardiac surgery
- Keywords
- Atrial fibrillation, Aortic stenosis, Coronary artery disease, Cardiac surgery, Atrial appendage
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease, Heart Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Open heart surgery
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Patients with atrial fibrillation Receives: Procedure: Cardiac surgery | |
| Coronary bypass | Patients undergoing coronary bypass Receives: Procedure: Cardiac surgery | |
| Aortic valve replacement | Patients undergoing aortic valve replacement Receives: Procedure: Cardiac surgery | |
| Mitral valve repair | Patients undergoing mitral valve repair Receives: Procedure: Cardiac surgery | |
| Other | Patients undergoing cardiac surgery for indication other than above Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
Occurrence of atrial fibrillation
Measured: postoperatively until 5 years follow-up
Secondary outcomes (6)
Stroke
Occurrence of stroke
Measured: postoperatively until 5 years follow-up
Transient ischemic attack
Occurrence of Transient ischemic attack
Measured: postoperatively until 5 years follow-up
Myocardial infarction
Occurrence of Myocardial infarction
Measured: postoperatively until 5 years follow-up
Target vessel revascularization
Occurrence of Target vessel revascularization
Measured: postoperatively until 5 years follow-up
All-cause Mortality
All-cause Mortality
Measured: postoperatively until 5 years follow-up
Post-pericardiotomy syndrome
Occurrence of Post-pericardiotomy syndrome
Measured: postoperatively until 1 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Feb 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,001 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Tuomas Kiviniemi, University of Turku
- Investigators
- Tuomas O Kiviniemi, MD, PhD, Study director, Turku University HospitalJarmo Gunn, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444259
- Sponsor's protocol ID
- T273/2015
- Acronym
- CAREBANK
- Status last verified
- May 2024
- First submitted
- 15 Feb 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Viikinkoski E, Lehto J, Relander A, Jalkanen J, Gunn J, Vasankari T, Biancari F, Airaksinen JKE, Hollmen M, Kiviniemi TO. Prolonged Systemic Inflammatory Response Syndrome Predicts Atrial Fibrillation After Cardiac Surgery. Interdiscip Cardiovasc Thorac Surg. 2026 Mar 12;41(3):ivag081. doi: 10.1093/icvts/ivag081.
PubMed 41840772Maaniitty E, Sinisilta S, Jalkanen J, Vasankari T, Biancari F, Gunn J, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Distinct circulating cytokine levels in patients with angiography-proven coronary artery disease compared to disease-free controls. Int J Cardiol Cardiovasc Risk Prev. 2024 Jul 4;22:200307. doi: 10.1016/j.ijcrp.2024.200307. eCollection 2024 Sep.
PubMed 39091640Maaniitty E, Jalkanen J, Sinisilta S, Gunn J, Vasankari T, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Differential circulating cytokine profiles in acute coronary syndrome versus stable coronary artery disease. Sci Rep. 2024 Jul 27;14(1):17269. doi: 10.1038/s41598-024-68333-7.
PubMed 39068298Viikinkoski E, Jalkanen J, Gunn J, Vasankari T, Lehto J, Valtonen M, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi TO. Red blood cell transfusion induces abnormal HIF-1alpha response to cytokine storm after adult cardiac surgery. Sci Rep. 2021 Nov 15;11(1):22230. doi: 10.1038/s41598-021-01695-4.
PubMed 34782683
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
- Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
- ClinicalTrials.gov ID
- NCT03444259
- Acronym / sponsor ID
- CAREBANK / T273/2015
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease, Mitral Valve Disease, Cardiac Arrythmias
- Keywords
- Atrial fibrillation, Aortic stenosis, Coronary artery disease, Cardiac surgery, Atrial appendage
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Feb 2018 (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.
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role of inflammation in atrial fibrillation.
Detailed description
The investigators aim to A) compare atrial cardiomyopathy findings from the tissue samples to clinical phenotype and adverse events B) study the association of genetic defects predisposing to atrial fibrillation with atrial cardiomyopathy findings in the tissue samples C) assess the role of inflammation in atrial fibrillation by comparing circulating cytokine profiles, purinergic signaling and atrial cardiomyopathy findings in tissue samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | Procedure: Cardiac surgeryPatients with atrial fibrillation |
| Coronary bypass | – | Procedure: Cardiac surgeryPatients undergoing coronary bypass |
| Aortic valve replacement | – | Procedure: Cardiac surgeryPatients undergoing aortic valve replacement |
| Mitral valve repair | – | Procedure: Cardiac surgeryPatients undergoing mitral valve repair |
| Other | – | Procedure: Cardiac surgeryPatients undergoing cardiac surgery for indication other than above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing open-heart cardiac surgery
Key inclusion criteria (3 listed)
- Any open-heart cardiac surgery
- Written informed consent
- All-comers design
Key exclusion criteria (1 listed)
- No informed consent
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 |
|---|---|---|
| Cardiac surgeryOpen heart surgery | Procedure or surgery | Aortic valve replacement, Atrial fibrillation, Coronary bypass, Mitral valve repair, Other |
Primary outcome
Atrial fibrillation
Time frame: postoperatively until 5 years follow-up
Occurrence of atrial fibrillation
6 secondary outcomes
Stroke
Time frame: postoperatively until 5 years follow-up
Transient ischemic attack
Time frame: postoperatively until 5 years follow-up
Myocardial infarction
Time frame: postoperatively until 5 years follow-up
Target vessel revascularization
Time frame: postoperatively until 5 years follow-up
All-cause Mortality
Time frame: postoperatively until 5 years follow-up
Post-pericardiotomy syndrome
Time frame: postoperatively until 1 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41840772Viikinkoski E, Lehto J, Relander A, Jalkanen J, Gunn J, Vasankari T, Biancari F, Airaksinen JKE, Hollmen M, Kiviniemi TO. Prolonged Systemic Inflammatory Response Syndrome Predicts Atrial Fibrillation After Cardiac Surgery. Interdiscip Cardiovasc Thorac Surg. 2026 Mar 12;41(3):ivag081. doi: 10.1093/icvts/ivag081.
- Derived from this study: PubMed 39091640Maaniitty E, Sinisilta S, Jalkanen J, Vasankari T, Biancari F, Gunn J, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Distinct circulating cytokine levels in patients with angiography-proven coronary artery disease compared to disease-free controls. Int J Cardiol Cardiovasc Risk Prev. 2024 Jul 4;22:200307. doi: 10.1016/j.ijcrp.2024.200307. eCollection 2024 Sep.
- Derived from this study: PubMed 39068298Maaniitty E, Jalkanen J, Sinisilta S, Gunn J, Vasankari T, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Differential circulating cytokine profiles in acute coronary syndrome versus stable coronary artery disease. Sci Rep. 2024 Jul 27;14(1):17269. doi: 10.1038/s41598-024-68333-7.
- Derived from this study: PubMed 34782683Viikinkoski E, Jalkanen J, Gunn J, Vasankari T, Lehto J, Valtonen M, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi TO. Red blood cell transfusion induces abnormal HIF-1alpha response to cytokine storm after adult cardiac surgery. Sci Rep. 2021 Nov 15;11(1):22230. doi: 10.1038/s41598-021-01695-4.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Tuomas O Kiviniemi, MD, PhD study director
Turku University Hospital
Jarmo Gunn, MD, PhD principal investigator
Turku University Hospital
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 Coronary Artery Disease, 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?
The sponsor lists 3 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
Atrial fibrillation (time frame: postoperatively until 5 years follow-up). 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 NCT03444259, which also lists 4 linked publications.
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.