ClinicalTrials.gg
Active, not recruitingNCT03444259CAREBANKUpdated May 8, 2024

Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients

An observational study in Atrial Fibrillation, Coronary Artery Disease and Aortic Valve Stenosis, sponsored by University of Turku. Active, not recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Turku · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,001
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Atrial Fibrillation by University of Turku — 1 open to participants now, 3 under way, none of them phase 3. Atrial Fibrillation · University of Turku.

Started
2016
with 1 other
Observational
9 of 11
1 open now
Registered
7th of 11
by date

Among the 11 studies in Atrial Fibrillation by University of Turku, this one is one of 2 that started in 2016, is one of 9 observational ones, and was the 7th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

1 of the 11 studies in Atrial Fibrillation by University of Turku is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes.

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02

Study 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. 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.

03

Conditions studied

  • Atrial Fibrillation
  • Coronary Artery Disease
  • Aortic Valve Stenosis
  • Aortic Valve Disease
  • Mitral Valve Disease
  • Cardiac Arrythmias
  • Cardiac Tumor
  • Cardiac Surgery

Keywords

  • Atrial fibrillation
  • Aortic stenosis
  • Coronary artery disease
  • Cardiac surgery
  • Atrial appendage
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Consecutive patients undergoing open-heart cardiac surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any open-heart cardiac surgery
  • Written
  • All-comers design

Exclusion criteria

Exclusion Criteria:

  • No
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,001 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Atrial fibrillation

    Patients with atrial fibrillation

    Procedure: Cardiac surgery

  • Coronary bypass

    Patients undergoing coronary bypass

    Procedure: Cardiac surgery

  • Aortic valve replacement

    Patients undergoing aortic valve replacement

    Procedure: Cardiac surgery

  • Mitral valve repair

    Patients undergoing mitral valve repair

    Procedure: Cardiac surgery

  • Other

    Patients undergoing cardiac surgery for indication other than above

    Procedure: Cardiac surgery

Interventions

  • ProcedureCardiac surgery

    Open heart surgery

06

What researchers measure

Primary outcomes

  1. Atrial fibrillation

    Occurrence of atrial fibrillation

    Time frame: postoperatively until 5 years follow-up

Secondary outcomes

  1. Stroke

    Occurrence of stroke

    Time frame: postoperatively until 5 years follow-up

  2. Transient ischemic attack

    Occurrence of Transient ischemic attack

    Time frame: postoperatively until 5 years follow-up

  3. Myocardial infarction

    Occurrence of Myocardial infarction

    Time frame: postoperatively until 5 years follow-up

  4. Target vessel revascularization

    Occurrence of Target vessel revascularization

    Time frame: postoperatively until 5 years follow-up

  5. All-cause Mortality

    All-cause Mortality

    Time frame: postoperatively until 5 years follow-up

  6. Post-pericardiotomy syndrome

    Occurrence of Post-pericardiotomy syndrome

    Time frame: postoperatively until 1 years follow-up

07

Study locations

1 site
08

References and documents

Publications

  • Viikinkoski 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2016 (actual). Primary completion is estimated for Dec 2026, 130 months after the start.

Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 130 months is above that.

Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Feb 23, 2018
StartActual
Feb 1, 2016
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2029
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03444259
Responsible party
Tuomas Kiviniemi (Cardiologist, MD, PhD, FESC, University of Turku) — Principal investigator
First posted
Feb 23, 2018
Start date
Feb 1, 2016
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
May 8, 2024

Study contacts

Tuomas O Kiviniemi, MD, PhD
study director · Turku University Hospital
Jarmo Gunn, MD, PhD
principal investigator · Turku University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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