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In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative atrial fibrillation and complications will be assessed. The primary objective is to determine, whether SDB patients have a higher rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no SDB | apnea-hyponea index <15/hour |
| |
| SDB | apnea-hyponea index >=15/hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratification, no intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | periprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative atrial fibrillation (POAF) | assessed by ECG | 30 days after CABG surgery |
| Stroke | assessed by questionnaire | within 1 year after CABG surgery |
| Measure | Description | Time Frame |
|---|---|---|
| peri- and postoperative respiratory complications (difficult intubation, hypoxemia, respiratory failure, use of extracorporal mechanical oxygenation device) | Assessed from standardized routine clinical records | 30 days after CABG surgery |
| peri- and postoperative hemodynamic instability and heart failure |
Inclusion Criteria:
Exclusion Criteria:
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Eligible patients will be consecutive patients undergoing elective CABG surgery in stable hemodynamic condition. Only individuals who can give written informed consent will be included. Gender distribution will be according to the gender distribution of patients undergoing elective CABG surgery, since consecutive patients without gender selection will be studied.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Arzt, MD | Contact | +49 941 944 7281 | michael.arzt@ukr.de | |
| Stefan Wagner, MD | Contact | +49 941 944 7211 | stefan.wagner@ukr.de |
| Name | Affiliation | Role |
|---|---|---|
| Lars S Maier, MD | University Hospital Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine II, University Hospital | Recruiting | Regensburg | 93055 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37893039 | Derived | Tafelmeier M, Blagoeva VG, Trum M, Hegner P, Floerchinger B, Camboni D, Creutzenberg M, Zeman F, Schmid C, Maier LS, Wagner S, Linz D, Baumert M, Arzt M. Predictors of Nocturnal Hypoxemic Burden in Patients Undergoing Elective Coronary Artery Bypass Grafting Surgery. Biomedicines. 2023 Sep 28;11(10):2665. doi: 10.3390/biomedicines11102665. | |
| 34517118 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D012891 | Sleep Apnea Syndromes |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| MACCE | assessed by questionnaire | within 1 and 2 years after CABG surgery |
| Major pulmonary complications | assessed by questionnaire | within 30 days as well as 1 and 2 years |
(medical records) |
| 30 days after CABG surgery |
| postoperative enzymatic myocardial injury | (medical records) | 30 days after CABG surgery |
| postoperative acute kidney injury | (medical records) | 30 days after CABG surgery |
| postoperative delirium | (Questionnaire) | 30 days after CABG surgery |
| general quality of life | (EuroQol - Questionnaire) | 30 days after CABG surgery |
| disease specific quality of life | (Atrial Fibrillation Effect on Quality of Life - Questionnaire) | 30 days after CABG surgery |
| disease specific quality of life | (Seattle Angina Questionnaire) | 30 days after CABG surgery |
| Hegner P, Lebek S, Tafelmeier M, Camboni D, Schopka S, Schmid C, Maier LS, Arzt M, Wagner S. Sleep-disordered breathing is independently associated with reduced atrial connexin 43 expression. Heart Rhythm. 2021 Dec;18(12):2187-2194. doi: 10.1016/j.hrthm.2021.09.009. Epub 2021 Sep 10. |
| 34124106 | Derived | Lebek S, Hegner P, Tafelmeier M, Rupprecht L, Schmid C, Maier LS, Arzt M, Wagner S. Female Patients With Sleep-Disordered Breathing Display More Frequently Heart Failure With Preserved Ejection Fraction. Front Med (Lausanne). 2021 May 28;8:675987. doi: 10.3389/fmed.2021.675987. eCollection 2021. |
| 32798522 | Derived | Tafelmeier M, Luft L, Zistler E, Floerchinger B, Camboni D, Creutzenberg M, Zeman F, Schmid C, Maier LS, Wagner S, Arzt M. Central Sleep Apnea Predicts Pulmonary Complications After Cardiac Surgery. Chest. 2021 Feb;159(2):798-809. doi: 10.1016/j.chest.2020.07.080. Epub 2020 Aug 13. |
| 31902278 | Derived | Lebek S, Pichler K, Reuthner K, Trum M, Tafelmeier M, Mustroph J, Camboni D, Rupprecht L, Schmid C, Maier LS, Arzt M, Wagner S. Enhanced CaMKII-Dependent Late INa Induces Atrial Proarrhythmic Activity in Patients With Sleep-Disordered Breathing. Circ Res. 2020 Feb 28;126(5):603-615. doi: 10.1161/CIRCRESAHA.119.315755. Epub 2020 Jan 6. |
| 31109986 | Derived | Tafelmeier M, Knapp M, Lebek S, Floerchinger B, Camboni D, Creutzenberg M, Wittmann S, Zeman F, Schmid C, Maier LS, Wagner S, Arzt M. Predictors of delirium after cardiac surgery in patients with sleep disordered breathing. Eur Respir J. 2019 Aug 8;54(2):1900354. doi: 10.1183/13993003.00354-2019. Print 2019 Aug. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |