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

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ClinicalTrials.gov Identifier: NCT03444259

Recruitment Status : Recruiting

First Posted : February 23, 2018

Last Update Posted : April 28, 2021

See Contacts and Locations

Sponsor:

Collaborator:

Brigham and Women's Hospital

Information provided by (Responsible Party):

Tuomas Kiviniemi, University of Turku

Study Description

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation Coronary Artery Disease Aortic Valve Stenosis Aortic Valve Disease Mitral Valve Disease Cardiac Arrythmias Cardiac Tumor Cardiac Surgery	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 Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	2000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	5 Years
Official Title:	Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
Actual Study Start Date :	February 1, 2016
Estimated Primary Completion Date :	December 31, 2025
Estimated Study Completion Date :	December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Supravalvular aortic stenosis Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Heart Surgery

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis Heart Tumor

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Biospecimen Retention: Samples With DNA

Atrial appendage, valves, ascending aorta, pericardium

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

Consecutive patients undergoing open-heart cardiac surgery

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No informed consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444259

Contacts

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Contact: Tuija Vasankari, RN	+35823130900	tuija.vasankari@tyks.fi

Locations

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Finland
Turku University Hospital	Recruiting
Turku, Finland, 20520
Contact: Tuomas Kiviniemi, MD, PhD +35823130787 tuoski@utu.fi
Contact: Tuija Vasankari, RN +35823130900 tuija.vasankari@tyks.fi
Principal Investigator: Jarmo Gunn, MD, PhD
Sub-Investigator: Maija Hollmen, PhD

Sponsors and Collaborators

University of Turku

Brigham and Women's Hospital

Investigators

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Study Director:	Tuomas O Kiviniemi, MD, PhD	Turku University Hospital
Principal Investigator:	Jarmo Gunn, MD, PhD	Turku University Hospital

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Viikinkoski E, Jalkanen J, Gunn J, Vasankari T, Lehto J, Valtonen M, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmén M, Kiviniemi TO. Red blood cell transfusion induces abnormal HIF-1α response to cytokine storm after adult cardiac surgery. Sci Rep. 2021 Nov 15;11(1):22230. doi: 10.1038/s41598-021-01695-4.

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Responsible Party:	Tuomas Kiviniemi, Cardiologist, MD, PhD, FESC, University of Turku
ClinicalTrials.gov Identifier:	NCT03444259
Other Study ID Numbers:	T273/2015
First Posted:	February 23, 2018 Key Record Dates
Last Update Posted:	April 28, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Tuomas Kiviniemi, University of Turku:


Atrial fibrillation Aortic stenosis Coronary artery disease Cardiac surgery Atrial appendage

Additional relevant MeSH terms:

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Heart Neoplasms Atrial Fibrillation Coronary Artery Disease Myocardial Ischemia Coronary Disease Arrhythmias, Cardiac Aortic Valve Stenosis Aortic Valve Disease Heart Diseases Cardiovascular Diseases	Pathologic Processes Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Heart Valve Diseases Ventricular Outflow Obstruction Thoracic Neoplasms Neoplasms by Site Neoplasms

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