Clinical trial NCT03444259: Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
Official title: Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2018-02-23
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing open-heart cardiac surgery

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Atrial fibrillation
timeFrame: postoperatively until 5 years follow-up
Secondary outcomes:
measure: Stroke
timeFrame: postoperatively until 5 years follow-up
measure: Transient ischemic attack
timeFrame: postoperatively until 5 years follow-up
measure: Myocardial infarction
timeFrame: postoperatively until 5 years follow-up
measure: Target vessel revascularization
timeFrame: postoperatively until 5 years follow-up
measure: All-cause Mortality
timeFrame: postoperatively until 5 years follow-up
measure: Post-pericardiotomy syndrome
timeFrame: postoperatively until 1 years follow-up
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Tuomas O Kiviniemi, MD, PhD
role: STUDY_DIRECTOR
affiliation: Turku University Hospital
name: Jarmo Gunn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.