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

NCT03444259 — Active not recruiting, 1001 participants, University of Turku
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Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients

RegistryNCT03444259, acronym CAREBANK
StatusActive not recruiting
Study typeObservational
Enrollment1001 (Actual)
SponsorUniversity of Turku (Other); collaborators: Brigham and Women's Hospital
ConditionsAtrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease, Mitral Valve Disease, Cardiac Arrythmias, Cardiac Tumor, Cardiac Surgery
InterventionsCardiac surgery (Procedure)
Datesstart 2016-02-01, primary completion 2026-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2018-02-23, last updated 2024-05-08
Locations1 site in Finland

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Atrial fibrillationProcedure: Cardiac surgeryPatients with atrial fibrillation
Coronary bypassProcedure: Cardiac surgeryPatients undergoing coronary bypass
Aortic valve replacementProcedure: Cardiac surgeryPatients undergoing aortic valve replacement
Mitral valve repairProcedure: Cardiac surgeryPatients undergoing mitral valve repair
OtherProcedure: Cardiac surgeryPatients undergoing cardiac surgery for indication other than above
  • Cardiac surgery (Procedure): Open heart surgery

+Outcome measures

Primary outcomes

  • Atrial fibrillation [postoperatively until 5 years follow-up]: Occurrence of atrial fibrillation

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* No informed consent

+Locations (1)

FacilityCityCountryStatus
Turku University HospitalTurkuFinland

+Publications

  • Results publication: 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. PMID 41840772
  • Results publication: Maaniitty 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. PMID 39091640
  • Results publication: Maaniitty 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. PMID 39068298
  • Results publication: 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. PMID 34782683

+Investigators

My Notes