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Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02877745
Acronym
CONSIDER-AF
Enrollment
1200
Registered
2016-08-24
Start date
2016-07-31
Completion date
2024-05-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Coronary Artery Disease, Elective Coronary Artery Bypass Grafting (CABG) Surgery, Sleep-disordered Breathing (SDB)

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.

Interventions

OTHERStratification, no intervention

Sponsors

Michael Arzt
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiac and Cerebrovascular Events (MACCE)30 daysperiprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality

Secondary

MeasureTime frameDescription
MACCEwithin 1 and 2 years after CABG surgeryassessed by questionnaire
Major pulmonary complicationswithin 30 days as well as 1 and 2 yearsassessed by questionnaire
Strokewithin 1 year after CABG surgeryassessed by questionnaire
postoperative atrial fibrillation (POAF)30 days after CABG surgeryassessed by ECG

Other

MeasureTime frameDescription
postoperative enzymatic myocardial injury30 days after CABG surgery(medical records)
postoperative acute kidney injury30 days after CABG surgery(medical records)
postoperative delirium30 days after CABG surgery(Questionnaire)
general quality of life30 days after CABG surgery(EuroQol - Questionnaire)
disease specific quality of life30 days after CABG surgery(Atrial Fibrillation Effect on Quality of Life - Questionnaire)
peri- and postoperative respiratory complications (difficult intubation, hypoxemia, respiratory failure, use of extracorporal mechanical oxygenation device)30 days after CABG surgeryAssessed from standardized routine clinical records
peri- and postoperative hemodynamic instability and heart failure30 days after CABG surgery(medical records)

Countries

Germany

Contacts

Primary ContactMichael Arzt, MD
michael.arzt@ukr.de+49 941 944 7281
Backup ContactStefan Wagner, MD
stefan.wagner@ukr.de+49 941 944 7211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026