Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

NCT ID: NCT02877745

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elective Coronary Artery Bypass Grafting (CABG) Surgery Coronary Artery Disease Sleep-disordered Breathing (SDB) Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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no SDB

apnea-hyponea index \<15/hour

Stratification, no intervention

Intervention Type OTHER

SDB

apnea-hyponea index \>=15/hour

Stratification, no intervention

Intervention Type OTHER

Interventions

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Stratification, no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael Arzt

OTHER

Sponsor Role lead

Responsible Party

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Michael Arzt

Coordinating Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lars S Maier, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Regensburg

Locations

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Department of Internal Medicine II, University Hospital

Regensburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Arzt, MD

Role: CONTACT

+49 941 944 7281

Stefan Wagner, MD

Role: CONTACT

+49 941 944 7211

Facility Contacts

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Michael Arzt, MD

Role: primary

+49 941 944 7281

Stefan Wagner, MD

Role: backup

+49 941 944 7211

References

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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.

Reference Type DERIVED
PMID: 37893039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34517118 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34124106 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32798522 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31902278 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31109986 (View on PubMed)

Other Identifiers

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3643420

Identifier Type: -

Identifier Source: org_study_id

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