Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

Overview

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.

Full Title of Study: “ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2024

Interventions

  • Other: Stratification, no intervention

Arms, Groups and Cohorts

  • no SDB
    • apnea-hyponea index <15/hour
  • SDB
    • apnea-hyponea index >=15/hour

Clinical Trial Outcome Measures

Primary Measures

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE)
    • Time Frame: 30 days
    • periprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality

Secondary Measures

  • postoperative atrial fibrillation (POAF)
    • Time Frame: 30 days after CABG surgery
    • assessed by ECG
  • Stroke
    • Time Frame: within 1 year after CABG surgery
    • assessed by questionnaire
  • MACCE
    • Time Frame: within 1 and 2 years after CABG surgery
    • assessed by questionnaire
  • Major pulmonary complications
    • Time Frame: within 30 days as well as 1 and 2 years
    • assessed by questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Michael Arzt
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Michael Arzt, Coordinating Investigator – University Hospital Regensburg
  • Overall Official(s)
    • Lars S Maier, MD, Principal Investigator, University Hospital Regensburg
  • Overall Contact(s)
    • Michael Arzt, MD, +49 941 944 7281, michael.arzt@ukr.de

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