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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Atrial Fibrillation; Aortic Valve Stenosis; Aortic Valve Disease; Cardiac Surgery; Cardiac Arrythmias; Mitral Valve Disease; Cardiac Tumor
• Intervention / Treatment: Procedure: Cardiac surgery

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 Type: Observational
• Enrollment (Actual): 1001

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing open-heart cardiac surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atrial fibrillation; Patients with atrial fibrillation	Procedure: Cardiac surgery; Open heart surgery
Coronary bypass; Patients undergoing coronary bypass	Procedure: Cardiac surgery; Open heart surgery
Aortic valve replacement; Patients undergoing aortic valve replacement	Procedure: Cardiac surgery; Open heart surgery
Mitral valve repair; Patients undergoing mitral valve repair	Procedure: Cardiac surgery; Open heart surgery
Other; Patients undergoing cardiac surgery for indication other than above	Procedure: Cardiac surgery; Open heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	Occurrence of atrial fibrillation	postoperatively until 5 years follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Turku
• Collaborators: Brigham and Women's Hospital
• Investigators: Study Director: Tuomas O Kiviniemi, MD, PhD, Turku University Hospital; Principal Investigator: Jarmo Gunn, MD, PhD, Turku University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Atrial fibrillation; Cardiac surgery; Aortic stenosis; Atrial appendage
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neoplasms; Neoplasms by Site; Thoracic Neoplasms; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atrial Fibrillation; Aortic Valve Stenosis; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Neoplasms
• Other Study ID Numbers: T273/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No