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

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.

Conditions studied

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

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Keywords

Atrial fibrillation
Aortic stenosis
Coronary artery disease
Cardiac surgery
Atrial appendage

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

Inclusion criteria

Any open-heart cardiac surgery
Written informed consent
All-comers design

Exclusion criteria

Exclusion Criteria:

No informed consent

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

What researchers measure

Primary outcomes

Atrial fibrillation
Occurrence of atrial fibrillation
Time frame: postoperatively until 5 years follow-up

Secondary outcomes

Stroke
Occurrence of stroke
Time frame: postoperatively until 5 years follow-up
Transient ischemic attack
Occurrence of Transient ischemic attack
Time frame: postoperatively until 5 years follow-up
Myocardial infarction
Occurrence of Myocardial infarction
Time frame: postoperatively until 5 years follow-up
Target vessel revascularization
Occurrence of Target vessel revascularization
Time frame: postoperatively until 5 years follow-up
All-cause Mortality
All-cause Mortality
Time frame: postoperatively until 5 years follow-up
Post-pericardiotomy syndrome
Occurrence of Post-pericardiotomy syndrome
Time frame: postoperatively until 1 years follow-up

Study locations

1 site

Turku University Hospital
Turku, 20520, Finland

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

Registry details

Key details

Study ID: NCT03444259
Lead sponsor: University of Turku
Collaborators: Brigham and Women's Hospital
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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