Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

Coronary Artery Disease Clinical Trial

— CONSIDER-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877745
• Other study ID #: 3643420
• Status: Recruiting
• Start date: July 2016
• Est. completion date: May 2024

Study information

• Verified date: September 2021
• Source: University Hospital Regensburg
• Contact: Michael Arzt, MD
• Phone: +49 941 944 7281
• Email: michael.arzt[@]ukr.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Elective Coronary Artery Bypass Grafting (CABG) Surgery
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-disordered Breathing (SDB)

Intervention

Other:
• Stratification, no intervention

Locations

Country	Name	City	State
Germany	Department of Internal Medicine II, University Hospital	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Michael Arzt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	peri- and postoperative hemodynamic instability and heart failure	(medical records)	30 days after CABG surgery
Other	postoperative enzymatic myocardial injury	(medical records)	30 days after CABG surgery
Other	postoperative acute kidney injury	(medical records)	30 days after CABG surgery
Other	postoperative delirium	(Questionnaire)	30 days after CABG surgery
Other	general quality of life	(EuroQol - Questionnaire)	30 days after CABG surgery
Other	disease specific quality of life	(Atrial Fibrillation Effect on Quality of Life - Questionnaire)	30 days after CABG surgery
Other	disease specific quality of life	(Seattle Angina Questionnaire)	30 days after CABG surgery
Primary	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	postoperative atrial fibrillation (POAF)	assessed by ECG	30 days after CABG surgery
Secondary	Stroke	assessed by questionnaire	within 1 year after CABG surgery
Secondary	MACCE	assessed by questionnaire	within 1 and 2 years after CABG surgery
Secondary	Major pulmonary complications	assessed by questionnaire	within 30 days as well as 1 and 2 years