Coronary Artery Disease Clinical Trial
— CONSIDER-AFOfficial title:
ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Internal Medicine II, University Hospital | Regensburg |
Lead Sponsor | Collaborator |
---|---|
Michael Arzt |
Germany,
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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