Study Results
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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RECRUITING
300 participants
OBSERVATIONAL
2024-11-25
2027-08-31
Brief Summary
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Detailed Description
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The aim of this project is to develop a predictive model for post-surgery CSDS in CABG patients using pre- and perioperative data. A prognostic prediction model for CSDS 6 weeks post-CABG, will be developed using demographic, psychometric, medical, inflammation, and cardiac interoception data. Machine learning algorithms will be employed for data analysis. A cohort of 350 participants from two hospitals will be recruited, with 300 participants expected to complete the study. Data will be divided into training (200 participants) and testing (100 participants) sets. Nested cross-validation will prevent overfitting. Both binary and regression prediction models will be used. Additionally, a simpler model will be developed to increase generalizability.
The prediction model will identify CABG patients at risk of post-surgery CSDS. The model will help identify patients at risk for CSDS before surgery, enabling early interventions. Clinicians can make precision medicine decisions to prevent or manage CSDS, improving postoperative psychological well-being. Additionally, the study could advance understanding of the mechanisms linking depression and coronary heart disease, particularly in relation to inflammation and interoception.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Training group
From the final cohort of 300 participants, 200 will be recruited at Hospital I (University Hospital Zurich) to form the training group for developing the optimal statistical model.
No interventions assigned to this group
Test group
From the final cohort of 300 participants, the remaining 100 will be recruited at Hospital II (Stadtspital Zurich Triemli) to form the test group for validating the final model.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Men and women, aged between 18 and 90 years
* Sufficient knowledge of German language in reading and understanding
* Oral and Signed consent form
* Ability and Willingness to follow the study protocol
Exclusion Criteria
* Any serious comorbid non-cardiac medical condition likely to cause death within 1 year (e.g. metastatic cancer)
* Active psychotic symptoms (assessed with two items from the Youth Psychosis At Risk Questionnaire), substance abuse and/or dependence within the past 6 months (assessed with a single-item questionnaire), and/or active suicidal ideations (assessed with a single item from the M.I.N.I.).
* Acute or emergency CABG
18 Years
90 Years
ALL
No
Sponsors
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Triemli Hospital
OTHER
ETH Zurich
OTHER
University of Zurich
OTHER
Roland von Känel
OTHER
Responsible Party
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Roland von Känel
Prof. Dr. med.
Principal Investigators
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Omer Dzemali, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Stadtspital Zürich Triemli, Klinik für Herzchirurgie, Birmensdorferstr. 497, 8063 Zurich, Switzerland
Roland v Känel, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Dept. of Consultation-Liaison Psychiatry, Haldenbachstr. 16/18, 8091 Zurich, Switzerland
Locations
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Stadtspital Zürich (City Hospital Zurich) Triemli
Zurich, , Switzerland
University Hospital Zurich (USZ)
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Chocron S, Vandel P, Durst C, Laluc F, Kaili D, Chocron M, Etievent JP. Antidepressant therapy in patients undergoing coronary artery bypass grafting: the MOTIV-CABG trial. Ann Thorac Surg. 2013 May;95(5):1609-18. doi: 10.1016/j.athoracsur.2013.02.035. Epub 2013 Apr 6.
Correa-Rodriguez M, Abu Ejheisheh M, Suleiman-Martos N, Membrive-Jimenez MJ, Velando-Soriano A, Schmidt-RioValle J, Gomez-Urquiza JL. Prevalence of Depression in Coronary Artery Bypass Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Mar 26;9(4):909. doi: 10.3390/jcm9040909.
Guo P. Preoperative education interventions to reduce anxiety and improve recovery among cardiac surgery patients: a review of randomised controlled trials. J Clin Nurs. 2015 Jan;24(1-2):34-46. doi: 10.1111/jocn.12618. Epub 2014 Jun 3.
Protogerou C, Fleeman N, Dwan K, Richardson M, Dundar Y, Hagger MS. Moderators of the effect of psychological interventions on depression and anxiety in cardiac surgery patients: A systematic review and meta-analysis. Behav Res Ther. 2015 Oct;73:151-64. doi: 10.1016/j.brat.2015.08.004. Epub 2015 Aug 14.
Ravven S, Bader C, Azar A, Rudolph JL. Depressive symptoms after CABG surgery: a meta-analysis. Harv Rev Psychiatry. 2013 Mar-Apr;21(2):59-69. doi: 10.1097/HRP.0b013e31828a3612.
Takagi H, Ando T, Umemoto T; ALICE (All-Literature Investigation of Cardiovascular Evidence) Group. Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels. 2017 Dec;32(12):1458-1468. doi: 10.1007/s00380-017-1022-3. Epub 2017 Jul 13.
Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018.
Related Links
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SNF-Grant
Other Identifiers
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215033
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BASEC 2023-02040
Identifier Type: -
Identifier Source: org_study_id
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