NCT02877745

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

7.8 years

First QC Date

July 31, 2016

Last Update Submit

September 14, 2021

Conditions

Elective Coronary Artery Bypass Grafting (CABG) SurgeryCoronary Artery DiseaseSleep-disordered Breathing (SDB)Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • postoperative atrial fibrillation (POAF)

    30 days after CABG surgery

  • Stroke

    within 1 year after CABG surgery

  • MACCE

    within 1 and 2 years after CABG surgery

  • Major pulmonary complications

    within 30 days as well as 1 and 2 years

Other Outcomes (8)

  • peri- and postoperative respiratory complications (difficult intubation, hypoxemia, respiratory failure, use of extracorporal mechanical oxygenation device)

    30 days after CABG surgery

  • peri- and postoperative hemodynamic instability and heart failure

    30 days after CABG surgery

  • postoperative enzymatic myocardial injury

    30 days after CABG surgery

  • +5 more other outcomes

Study Arms (2)

no SDB

apnea-hyponea index \<15/hour

Other: Stratification, no intervention

SDB

apnea-hyponea index \>=15/hour

Other: Stratification, no intervention

Interventions

Stratification, no interventionOTHER
SDBno SDB

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients undergoing elective CABG surgery at the Department of Cardiac and Thoracic Surgery, University Hospital Regensburg.
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine II, University Hospital

Regensburg, 93055, Germany

RECRUITING

Related Publications (6)

  • Tafelmeier M, Blagoeva VG, Trum M, Hegner P, Floerchinger B, Camboni D, Creutzenberg M, Zeman F, Schmid C, Maier LS, Wagner S, Linz D, Baumert M, Arzt M. Predictors of Nocturnal Hypoxemic Burden in Patients Undergoing Elective Coronary Artery Bypass Grafting Surgery. Biomedicines. 2023 Sep 28;11(10):2665. doi: 10.3390/biomedicines11102665.

    PMID: 37893039DERIVED

  • Hegner P, Lebek S, Tafelmeier M, Camboni D, Schopka S, Schmid C, Maier LS, Arzt M, Wagner S. Sleep-disordered breathing is independently associated with reduced atrial connexin 43 expression. Heart Rhythm. 2021 Dec;18(12):2187-2194. doi: 10.1016/j.hrthm.2021.09.009. Epub 2021 Sep 10.

    PMID: 34517118DERIVED

  • Lebek S, Hegner P, Tafelmeier M, Rupprecht L, Schmid C, Maier LS, Arzt M, Wagner S. Female Patients With Sleep-Disordered Breathing Display More Frequently Heart Failure With Preserved Ejection Fraction. Front Med (Lausanne). 2021 May 28;8:675987. doi: 10.3389/fmed.2021.675987. eCollection 2021.

    PMID: 34124106DERIVED

  • Tafelmeier M, Luft L, Zistler E, Floerchinger B, Camboni D, Creutzenberg M, Zeman F, Schmid C, Maier LS, Wagner S, Arzt M. Central Sleep Apnea Predicts Pulmonary Complications After Cardiac Surgery. Chest. 2021 Feb;159(2):798-809. doi: 10.1016/j.chest.2020.07.080. Epub 2020 Aug 13.

    PMID: 32798522DERIVED

  • Lebek S, Pichler K, Reuthner K, Trum M, Tafelmeier M, Mustroph J, Camboni D, Rupprecht L, Schmid C, Maier LS, Arzt M, Wagner S. Enhanced CaMKII-Dependent Late INa Induces Atrial Proarrhythmic Activity in Patients With Sleep-Disordered Breathing. Circ Res. 2020 Feb 28;126(5):603-615. doi: 10.1161/CIRCRESAHA.119.315755. Epub 2020 Jan 6.

    PMID: 31902278DERIVED

  • Tafelmeier M, Knapp M, Lebek S, Floerchinger B, Camboni D, Creutzenberg M, Wittmann S, Zeman F, Schmid C, Maier LS, Wagner S, Arzt M. Predictors of delirium after cardiac surgery in patients with sleep disordered breathing. Eur Respir J. 2019 Aug 8;54(2):1900354. doi: 10.1183/13993003.00354-2019. Print 2019 Aug.

    PMID: 31109986DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseSleep Apnea SyndromesAtrial Fibrillation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lars S Maier, MD

    University Hospital Regensburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Arzt, MD

CONTACT

+49 941 944 7281michael.arzt@ukr.de

Stefan Wagner, MD

CONTACT

+49 941 944 7211stefan.wagner@ukr.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 24, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

DE(1)