Depressive Symptoms After Cardiac Surgery

NCT06706323 | Recruiting

• 2 other identifiers: BASEC 2023-02040215033
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9) score ≥10 (yes/no) at 6 weeks post-CABG

  The Patient Health Questionnaire (PHQ)-9 will assess the severity of self-rated depressive symptoms over the last two weeks. It covers the nine Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for major depression, with symptoms rated on a 4-point Likert scale. Scores range from 0 to 27, with higher scores indicating more severe symptoms. A score of 10 or higher corresponds to a diagnosis of depression, with 88 percent sensitivity and specificity. As the best cut-off for post-CABG CSDS is difficult to determine a priori for a prediction model, a two complementary approaches for the analysis will be used, correcting for multiple tests when assessing the significance of the accuracy of the prediction model. One approach frames the prediction challenge as a binary classification problem and uses a PHQ-9 cut-off score ≥10 for defining the presence versus absence of CSDS.

  Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)

Secondary Outcomes (7)

• PHQ-9 score continuous at 6 weeks post-CABG

  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

  Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)

• GAD-7 score continuous at 6 weeks post-CABG

  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

  Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)

• PCL-5 score continuous at 6 weeks post-CABG

  Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roland von Känel: lead
• Triemli Hospital: collaborator
• ETH Zurich: collaborator
• University of Zurich: collaborator

Study Sites (2)

Stadtspital Zürich (City Hospital Zurich) Triemli

Zurich, 8063, Switzerland

RECRUITING

University Hospital Zurich (USZ)

Zurich, 8091, Switzerland

NOT YET RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21896369 BACKGROUND

Related Links

• SNF-Grant

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum.

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Heart Diseases; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being; Postoperative Complications; Inflammation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Omer Dzemali, Prof. Dr.

  Stadtspital Zürich Triemli, Klinik für Herzchirurgie, Birmensdorferstr. 497, 8063 Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

• Roland v Känel, Prof. Dr.

  University Hospital Zurich, Dept. of Consultation-Liaison Psychiatry, Haldenbachstr. 16/18, 8091 Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland v Känel, Prof. Dr.

CONTACT

+41 (0)44 255 52 51; roland.vonkaenel@usz.ch

Sinthujan Sivakumar, MSc

CONTACT

+41 (0)44 255 35 95; sinthujan.sivakumar@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CH (2)