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

Coronary Artery Disease Clinical Trial

— CAREBANK  

Official title:

Cardiovascular Research Consortium - a Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03444259
• Other study ID #: T273/2015
• Status: Active, not recruiting
• Start date: February 1, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1001
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrythmias
• Cardiac Surgery
• Cardiac Tumor
• Coronary Artery Disease
• Coronary Disease
• Mitral Valve Disease
• Myocardial Ischemia

Intervention

Procedure:
• Cardiac surgery
Open heart surgery

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Brigham and Women's Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation	Occurrence of atrial fibrillation	postoperatively until 5 years follow-up
Secondary	Stroke	Occurrence of stroke	postoperatively until 5 years follow-up
Secondary	Transient ischemic attack	Occurrence of Transient ischemic attack	postoperatively until 5 years follow-up
Secondary	Myocardial infarction	Occurrence of Myocardial infarction	postoperatively until 5 years follow-up
Secondary	Target vessel revascularization	Occurrence of Target vessel revascularization	postoperatively until 5 years follow-up
Secondary	All-cause Mortality	All-cause Mortality	postoperatively until 5 years follow-up
Secondary	Post-pericardiotomy syndrome	Occurrence of Post-pericardiotomy syndrome	postoperatively until 1 years follow-up