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Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillatio

Recruiting
Conditions
atrial fibrillation
heart rhythm disturbances
10007521
Registration Number
NL-OMON47800
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
150
Inclusion Criteria

- On-pump surgery
- Elective sternotomy for coronary artery bypass grafting or mitral valve
surgery or aorta- or aortic valve surgery
- CHADS VASC score >= 2
- Sinusrhythm
- Age between 18 and 80 years

Exclusion Criteria

- Documented or reported history atrial fibrillation, atrial flutter (duration
> 5 minutes) or ventricular tachycardia.
- Emergency or redo of CABG or valvular surgery
- Endocarditis, pericarditis
- Active systemic inflammation
- active malignancy
- NYHA class IV heart failure symptoms
- Left ventricular ejection fracton < 30%
- Pregnancy
- History of previous radiation therapy of the thorax

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p> Main study parameters are tissue miRNAs, atrial histopathology and blood<br /><br>biomarkers. Blood biomarkers will include miRNAs and markers of inflammation,<br /><br>oxidative stress, markers of fibrosis formation and circulating microRNAs.<br /><br>These will be correlated to the incidence of post-operative AF and the<br /><br>incidence of newly developed AF after 24 months follow-up. The study will be<br /><br>extended to five years.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Additional study parameters on the process of atrial remodeling and clinical<br /><br>data will be collected and include:<br /><br>- Cardiac imaging data<br /><br>- Clinical data on cardiac history<br /><br>- Assessment of stroke-free status<br /><br>- Epicardial mapping during thoracic surgery<br /><br>- Experienced health</p><br>
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