Clinical trial NCT06706323: Depressive Symptoms After Cardiac Surgery
Official title: Predictive Modelling of Clinically Significant Depressive Symptoms After Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Heart Diseases
Depression
Depressive Symptoms
Anxiety
Posttraumatic Stress Disorder
Quality of Life
Psychological Well-Being
Postoperative Complications
Keywords: Coronary Artery Bypass Graft
Coronary Artery Bypass Grafting
Coronary Artery Bypass Surgery
CABG
Inflammation
Interoception
Clinically Significant Depressive Symptoms
CSDS
Patient Health Questionnaire-9
PHQ-9
Postoperative Depression
Algorithms
Prediction
Predictive Modeling
Machine Learning
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Triemli Hospital
name: ETH Zurich
name: University of Zurich
First posted: 2024-11-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include 300 patients undergoing coronary artery bypass graft (CABG) surgery, recruited from two hospitals: the University Hospital Zurich (USZ) and the Municipal Hospital of Zurich - Triemli. Of these, 200 patients will be in the training group and 100 in the test group for developing and validating a predictive model for post-surgery depressive symptoms. Participants will be recruited consecutively, with inclusive criteria regarding sex and an upper age limit of 90 years to enhance eligibility and generalizability. As no literature suggests differences in depressive symptoms based on surgery type, patients will be included regardless of whether their CABG is isolated or combined with valve intervention.

Brief summary: 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.

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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9) score ≥10 (yes/no) at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
Secondary outcomes:
measure: PHQ-9 score continuous at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
measure: General Anxiety Disorder (GAD-7) score ≥10 (yes/no) at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
measure: GAD-7 score continuous at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
measure: PTSD (Post-traumatic Stress Disorder) Checklist for DSM-5 (PCL-5) score ≥33 at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
measure: PCL-5 score continuous at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
measure: Short-Form Health Survey-12 (SF-12) mental health component score at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
measure: SF-12 physical health component score at 6 weeks post-CABG
timeFrame: Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Stadtspital Zürich (City Hospital Zurich) Triemli
city: Zürich
country: Switzerland
facility: University Hospital Zurich (USZ)
Study officials:
affiliation: Stadtspital Zürich Triemli, Klinik für Herzchirurgie, Birmensdorferstr. 497, 8063 Zurich, Switzerland
name: Omer Dzemali, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Dept. of Consultation-Liaison Psychiatry, Haldenbachstr. 16/18, 8091 Zurich, Switzerland
name: Roland v Känel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.