Clinical trial NCT02877745: Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery
Official title: ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elective Coronary Artery Bypass Grafting (CABG) Surgery
Coronary Artery Disease
Sleep-disordered Breathing (SDB)
Atrial Fibrillation
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective CABG surgery at the Department of Cardiac and Thoracic Surgery, University Hospital Regensburg.
* Written informed consent

Exclusion Criteria:

* Preoperative use of inotropes or intra aortic balloon pump
* Severe obstructive pulmonary disease
* Patients on oxygen therapy, nocturnal positive airway pressure support or mechanical ventilation

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 30 days
Secondary outcomes:
measure: postoperative atrial fibrillation (POAF)
timeFrame: 30 days after CABG surgery
measure: Stroke
timeFrame: within 1 year after CABG surgery
measure: MACCE
timeFrame: within 1 and 2 years after CABG surgery
measure: Major pulmonary complications
timeFrame: within 30 days as well as 1 and 2 years
Other outcomes:
measure: peri- and postoperative respiratory complications (difficult intubation, hypoxemia, respiratory failure, use of extracorporal mechanical oxygenation device)
timeFrame: 30 days after CABG surgery
measure: peri- and postoperative hemodynamic instability and heart failure
timeFrame: 30 days after CABG surgery
measure: postoperative enzymatic myocardial injury
timeFrame: 30 days after CABG surgery
measure: postoperative acute kidney injury
timeFrame: 30 days after CABG surgery
measure: postoperative delirium
timeFrame: 30 days after CABG surgery
measure: general quality of life
timeFrame: 30 days after CABG surgery
measure: disease specific quality of life
timeFrame: 30 days after CABG surgery
measure: disease specific quality of life
timeFrame: 30 days after CABG surgery
Locations:
city: Regensburg
country: Germany
facility: Department of Internal Medicine II, University Hospital
Study officials:
affiliation: University Hospital Regensburg
name: Lars S Maier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.