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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02877745
Other study ID # 3643420
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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