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

• Sponsor: Michael Arzt (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02877745
• Collaborator: (none)
• Enrollment: 1,200
• Location: 1
• Duration (Months): 94
• Patients Per Site Per Month: 12.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Elective Coronary Artery Bypass Grafting (CABG) Surgery; Coronary Artery Disease; Sleep-disordered Breathing (SDB); Atrial Fibrillation	Other: Stratification, no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery
• Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Major Adverse Cardiac and Cerebrovascular Events (MACCE) [30 days]

   periprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality

Secondary Outcome Measures

1. postoperative atrial fibrillation (POAF) [30 days after CABG surgery]

   assessed by ECG

2. Stroke [within 1 year after CABG surgery]

   assessed by questionnaire

3. MACCE [within 1 and 2 years after CABG surgery]

   assessed by questionnaire

4. Major pulmonary complications [within 30 days as well as 1 and 2 years]

   assessed by questionnaire

Other Outcome Measures

1. peri- and postoperative respiratory complications (difficult intubation, hypoxemia, respiratory failure, use of extracorporal mechanical oxygenation device) [30 days after CABG surgery]

   Assessed from standardized routine clinical records

2. peri- and postoperative hemodynamic instability and heart failure [30 days after CABG surgery]

   (medical records)

3. postoperative enzymatic myocardial injury [30 days after CABG surgery]

   (medical records)

4. postoperative acute kidney injury [30 days after CABG surgery]

   (medical records)

5. postoperative delirium [30 days after CABG surgery]

   (Questionnaire)

6. general quality of life [30 days after CABG surgery]

   (EuroQol - Questionnaire)

7. disease specific quality of life [30 days after CABG surgery]

   (Atrial Fibrillation Effect on Quality of Life - Questionnaire)

8. disease specific quality of life [30 days after CABG surgery]

   (Seattle Angina Questionnaire)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine II, University Hospital	Regensburg		Germany	93055

Sponsors and Collaborators

• Michael Arzt

Investigators

• Principal Investigator: Lars S Maier, MD, University Hospital Regensburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Arzt, Coordinating Investigator, University Hospital Regensburg
• ClinicalTrials.gov Identifier: NCT02877745
• Other Study ID Numbers: 3643420
• First Posted: Aug 24, 2016
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• 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
• Additional relevant MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Atrial Fibrillation; Coronary Artery Disease

Study Results

No Results Posted as of Sep 16, 2021