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

NCT03444259 | Active Not Recruiting

• 1 other identifier: T273/2015
• Study Type: observational
• Target: 1,001
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  Occurrence of atrial fibrillation

  postoperatively until 5 years follow-up

Secondary Outcomes (6)

• Stroke

  postoperatively until 5 years follow-up

• Transient ischemic attack

  postoperatively until 5 years follow-up

• Myocardial infarction

  postoperatively until 5 years follow-up

• Target vessel revascularization

  postoperatively until 5 years follow-up

• All-cause Mortality

  postoperatively until 5 years follow-up

Study Arms (5)

Atrial fibrillation

Patients with atrial fibrillation

Procedure: Cardiac surgery

Coronary bypass

Patients undergoing coronary bypass

Procedure: Cardiac surgery

Aortic valve replacement

Patients undergoing aortic valve replacement

Procedure: Cardiac surgery

Mitral valve repair

Patients undergoing mitral valve repair

Procedure: Cardiac surgery

Other

Patients undergoing cardiac surgery for indication other than above

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

Open heart surgery

Aortic valve replacement; Atrial fibrillation; Coronary bypass; Mitral valve repair; Other

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing open-heart cardiac surgery

You may qualify if:

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

You may not qualify if:

• No informed consent

Sponsors & Collaborators

• University of Turku: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (3)

• Maaniitty E, Sinisilta S, Jalkanen J, Vasankari T, Biancari F, Gunn J, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Distinct circulating cytokine levels in patients with angiography-proven coronary artery disease compared to disease-free controls. Int J Cardiol Cardiovasc Risk Prev. 2024 Jul 4;22:200307. doi: 10.1016/j.ijcrp.2024.200307. eCollection 2024 Sep.

  PMID: 39091640 DERIVED

• Maaniitty E, Jalkanen J, Sinisilta S, Gunn J, Vasankari T, Biancari F, Jalkanen S, Airaksinen KEJ, Hollmen M, Kiviniemi T. Differential circulating cytokine profiles in acute coronary syndrome versus stable coronary artery disease. Sci Rep. 2024 Jul 27;14(1):17269. doi: 10.1038/s41598-024-68333-7.

  PMID: 39068298 DERIVED

• 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.

  PMID: 34782683 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Atrial appendage, valves, ascending aorta, pericardium

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Disease; Heart Neoplasms

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Tuomas O Kiviniemi, MD, PhD

  Turku University Hospital

  STUDY DIRECTOR

• Jarmo Gunn, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, MD, PhD, FESC

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 23, 2018
• Study Start: February 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

FI (1)