Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillatio
- Conditions
- atrial fibrillationheart rhythm disturbances10007521
- 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
- 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
- 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
Name Time Method <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
Name Time Method <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>