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

Active, not recruiting

• Conditions: Mitral Valve Disease; Cardiac Surgery; Aortic Valve Stenosis; Cardiac Arrythmias; Atrial Fibrillation; Cardiac Tumor; Coronary Artery Disease; Aortic Valve Disease
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT03444259
• Lead Sponsor: University of Turku

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.

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1001

Inclusion Criteria

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

Exclusion Criteria

• No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial fibrillation	Cardiac surgery	Patients with atrial fibrillation
Coronary bypass	Cardiac surgery	Patients undergoing coronary bypass
Mitral valve repair	Cardiac surgery	Patients undergoing mitral valve repair
Aortic valve replacement	Cardiac surgery	Patients undergoing aortic valve replacement
Other	Cardiac surgery	Patients undergoing cardiac surgery for indication other than above

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	postoperatively until 5 years follow-up	Occurrence of atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	postoperatively until 5 years follow-up	All-cause Mortality
Transient ischemic attack	postoperatively until 5 years follow-up	Occurrence of Transient ischemic attack
Stroke	postoperatively until 5 years follow-up	Occurrence of stroke
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
Post-pericardiotomy syndrome	postoperatively until 1 years follow-up	Occurrence of Post-pericardiotomy syndrome

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland