Depressive Symptoms After Cardiac Surgery

Official title

Predictive Modelling of Clinically Significant Depressive Symptoms After Coronary Artery Bypass Graft Surgery

Overview

The primary goal of this project is to develop a predictive model for clinically significant depressive symptoms (CSDS) in patients undergoing coronary artery bypass graft (CABG) surgery, using pre- and perioperative data. CSDS occur in about 30 percent of CABG patients, which is four times higher than in the general population. These symptoms are linked to poor quality of life and increased morbidity and mortality. The aim is to create a model that can identify patients at risk for postoperative depression. This tool could help clinicians make informed decisions and take preventive measures to manage depression after surgery.

Detailed description

In patients undergoing coronary artery bypass graft (CABG) surgery, the prevalence of clinically significant depressive symptoms (CSDS) is about 30 percent, four times higher than the 12-month prevalence in the general population. CSDS are associated with poor quality of life and increased morbidity and mortality. While several predictors of post-CABG CSDS have been identified, no prognostic model exists.

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.

Primary outcome measures

• Patient Health Questionnaire (PHQ-9) score ≥10 (yes/no) at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]

Secondary outcome measures (7)

• PHQ-9 score continuous at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]
• General Anxiety Disorder (GAD-7) score ≥10 (yes/no) at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]
• GAD-7 score continuous at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]
• PTSD (Post-traumatic Stress Disorder) Checklist for DSM-5 (PCL-5) score ≥33 at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]
• PCL-5 score continuous at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]
• Short-Form Health Survey-12 (SF-12) mental health component score at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]
• SF-12 physical health component score at 6 weeks post-CABG [Time frame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)]

Eligibility criteria

Inclusion criteria

• Elective Off-Pump CABG or CABG, either isolated or combined with valve intervention
• 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

• Cognitive impairment according to a score of ≤ 7 (maximum score = 9) on a modified version of a short version of the Mini-Mental State Examination and the Brief Interview for Mental Status
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Switzerland · 2 centers

• Stadtspital Zürich (City Hospital Zurich) Triemli — Zurich
• University Hospital Zurich (USZ) — Zurich

Publications

• 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. PMID 23566649
• 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. PMID 32225052
• 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. PMID 24894181
• 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. PMID 26319588
• 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. PMID 23656830
• 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. PMID 28702898
• 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. PMID 22916068
• 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.2011.07.01 PMID 21896369

Identifiers

NCT: NCT06706323 · BASEC 2023-02040 · 215033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗