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Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. This study aims to discover tissue and circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological processes underlying AF and are potential tools for risk stratification and prognosis or may become future targets of therapy.
This study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. Left atrial appendages, whole blood and epicardial mappings will be collected. Patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset AF.
Study procedures:
The left atrial appendage (LAA) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. Patients will be followed with regular 24-hour Holter investigations.
This study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. Patients will be recruited by the investigators during pre-operative assessment.
Clinical data will be gathered at baseline and stored in a customized microsoft access entry database. Statistical analysis will be performed in collaboration with the Bioinformatics Laboratory from the Academic Medical Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac surgery patients | The study cohort will comprise of patients without a history of AF that undergo cardiac surgery (CABG or mitral valve surgery) with increased CHADSVASC scores of ≥2. |
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| Measure | Description | Time Frame |
|---|---|---|
| incident Atrial Fibrillation | A de novo 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode within 2 years after surgery (with a blanking period for the postoperative period <30 days). | within 2 years after surgery |
| Postoperative Atrial Fibrillation | A 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode in the first 30 days following cardiac surgery or registered at the first 24h Holter monitoring if scheduled within 6 weeks following cardiac surgery. | within the first 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life defined by 36-Item Short Form Health Survey questionnaire | The quality of life is measured by 36-Item Short Form Health Survey questionnaires. | at 6 months and 1 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients are eligible that are referred to the investigators' tertiary cardiothoracic center for mitral valve surgery, (aortic) valve surgery or coronary artery bypass surgery and meet in- and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Joris de Groot, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | North Holland | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34332113 | Derived | van den Berg NWE, Neefs J, Kawasaki M, Nariswari FA, Wesselink R, Fabrizi B, Jongejan A, Klaver MN, Havenaar H, Hulsman EL, Wintgens LIS, Baalman SWE, Meulendijks ER, van Boven WJ, de Jong JSSG, van Putte BP, Driessen AHG, Boersma LVA, de Groot JR; PREDICT-AF Investigators. Extracellular matrix remodeling precedes atrial fibrillation: Results of the PREDICT-AF trial. Heart Rhythm. 2021 Dec;18(12):2115-2125. doi: 10.1016/j.hrthm.2021.07.059. Epub 2021 Jul 29. | |
| 31567634 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Left atrial appendages will be deep frozen and fixed Plasma samples and whole blood will be collected
| Derived |
| van den Berg NWE, Neefs J, Berger WR, Boersma LVA, van Boven WJ, van Putte BP, Kaya A, Kawasaki M, Driessen AHG, de Groot JR; PREDICT AF Investigators. PREventive left atrial appenDage resection for the predICtion of fuTure atrial fibrillation: design of the PREDICT AF study. J Cardiovasc Med (Hagerstown). 2019 Nov;20(11):752-761. doi: 10.2459/JCM.0000000000000868. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |