Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery (CONSIDER-AF)

ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Atrial Fibrillation; Sleep-disordered Breathing (SDB); Elective Coronary Artery Bypass Grafting (CABG) Surgery
• Intervention / Treatment: Other: Stratification, no intervention

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Michael Arzt, MD; Phone Number: +49 941 944 7281; Email: michael.arzt@ukr.de
• Study Contact Backup: Name: Stefan Wagner, MD; Phone Number: +49 941 944 7211; Email: stefan.wagner@ukr.de

Study Locations

• Germany
  • Regensburg, Germany, 93055
    • Recruiting
    • Department of Internal Medicine II, University Hospital
    • Contact: Michael Arzt, MD; Phone Number: +49 941 944 7281; Email: michael.arzt@ukr.de
    • Contact: Stefan Wagner, MD; Phone Number: +49 941 944 7211; Email: stefan.wagner@ukr.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no SDB; apnea-hyponea index <15/hour	Other: Stratification, no intervention
SDB; apnea-hyponea index >=15/hour	Other: Stratification, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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	(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

Collaborators and Investigators

• Sponsor: Michael Arzt
• Investigators: Principal Investigator: Lars S Maier, MD, University Hospital Regensburg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Circ Res. 2020 Apr 10;126(8):e60.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: July 31, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (ESTIMATE): August 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Sleep Apnea Syndromes; Respiratory Aspiration; Atrial Fibrillation
• Other Study ID Numbers: 3643420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes