Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02877745
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Arzt, University Hospital Regensburg

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
Elective Coronary Artery Bypass Grafting (CABG) Surgery Coronary Artery Disease Sleep-disordered Breathing (SDB) Atrial Fibrillation Other: Stratification, no intervention

Layout table for study information
Study Type : Observational
Estimated 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 : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
no SDB
apnea-hyponea index <15/hour
Other: Stratification, no intervention
SDB
apnea-hyponea index >=15/hour
Other: Stratification, no intervention



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. postoperative atrial fibrillation (POAF), assessed by ECG [ Time Frame: 30 days after CABG surgery ]
  2. Stroke, assessed by questionnaire [ Time Frame: within 1 year after CABG surgery ]
  3. MACCE, assessed by questionnaire [ Time Frame: within 1 and 2 years after CABG surgery ]
  4. Major pulmonary complications, assessed by questionnaire [ Time Frame: within 30 days as well as 1 and 2 years ]

Other Outcome Measures:
  1. peri- and postoperative respiratory complications (difficult intubation, hypoxemia, respiratory failure, use of extracorporal mechanical oxygenation device) [ Time Frame: 30 days after CABG surgery ]
  2. peri- and postoperative hemodynamic instability and heart failure (medical records) [ Time Frame: 30 days after CABG surgery ]
  3. postoperative enzymatic myocardial injury (medical records) [ Time Frame: 30 days after CABG surgery ]
  4. postoperative acute kidney injury (medical records) [ Time Frame: 30 days after CABG surgery ]
  5. postoperative delirium (Questionnaire) [ Time Frame: 30 days after CABG surgery ]
  6. general quality of life (EuroQol - Questionnaire) [ Time Frame: 30 days after CABG surgery ]
  7. disease specific quality of life (Atrial Fibrillation Effect on Quality of Life - Questionnaire) [ Time Frame: 30 days after CABG surgery ]
  8. disease specific quality of life (Seattle Angina Questionnaire) [ Time Frame: 30 days after CABG surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible patients will be consecutive patients undergoing elective CABG surgery in stable hemodynamic condition. Only individuals who can give written informed consent will be included. Gender distribution will be according to the gender distribution of patients undergoing elective CABG surgery, since consecutive patients without gender selection will be studied.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877745


Contacts
Layout table for location contacts
Contact: Michael Arzt, MD +49 941 944 7281 michael.arzt@ukr.de
Contact: Stefan Wagner, MD +49 941 944 7211 stefan.wagner@ukr.de

Locations
Layout table for location information
Germany
Department of Internal Medicine II, University Hospital Recruiting
Regensburg, Germany, 93055
Contact: Michael Arzt, MD    +49 941 944 7281    michael.arzt@ukr.de   
Contact: Stefan Wagner, MD    +49 941 944 7211    stefan.wagner@ukr.de   
Sponsors and Collaborators
Michael Arzt
Investigators
Layout table for investigator information
Principal Investigator: Lars S Maier, MD University Hospital Regensburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Arzt, Coordinating Investigator, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT02877745     History of Changes
Other Study ID Numbers: 3643420
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Respiratory Aspiration
Sleep Apnea Syndromes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases