Depressive Symptoms After Cardiac Surgery (PCD)

March 26, 2025 updated by: Roland von Känel

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8063
        • Recruiting
        • Stadtspital Zürich (City Hospital Zurich) Triemli
        • Contact:
        • Contact:
      • Zürich, Switzerland, 8091
        • Not yet recruiting
        • University Hospital Zurich (USZ)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

The PHQ-9 will assess the severity of self-rated depressive symptoms over the last two weeks. It covers the nine 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. The second approach views the prediction challenge as a regression problem and tries to predict individual PHQ-9 scores without applying any threshold.
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)

The General Anxiety Disorder (GAD)-7 questionnaire will assess self-rated anxiety symptoms over the past two weeks. Seven items are rated on a 4-point Likert scale, with total scores ranging from 0 to 21. A score of 10 or higher indicates moderate to severe anxiety, corresponding to a GAD diagnosis with 89% sensitivity and 82% specificity.

As the best cut-off for post-CABG GAD 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 GAD-7 cut-off score ≥10 for defining the presence versus absence of GAD.
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)

The GAD-7 questionnaire will assess self-rated anxiety symptoms over the past two weeks. Seven items are rated on a 4-point Likert scale, with total scores ranging from 0 to 21. A score of 10 or higher indicates moderate to severe anxiety, corresponding to a GAD diagnosis with 89% sensitivity and 82% specificity.

As the best cut-off for post-CABG GAD 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. The second approach views the prediction challenge as a regression problem and tries to predict individual GAD-7 scores without applying any threshold.
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)

The PTSD Checklist for DSM-5 (PCL-5) will assess CABG surgery-induced posttraumatic stress. It is a 20-item self-report measure evaluating the DSM-5 PTSD symptoms over the past month. Items are rated on a 5-point Likert scale, with scores of 33 or higher indicating probable PTSD.

As the best cut-off for post-CABG PTSD 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 PCL-5 cut-off score ≥33 for defining the presence versus absence of PTSD.
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)

The PCL-5 will assess CABG surgery-induced posttraumatic stress. It is a 20-item self-report measure evaluating the DSM-5 PTSD symptoms over the past month. Items are rated on a 5-point Likert scale, with scores of 33 or higher indicating probable PTSD.

As the best cut-off for post-CABG PTSD 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. The second approach views the prediction challenge as a regression problem and tries to predict individual PCL-5 scores without applying any threshold.
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)
The Short-Form Health Survey (SF-12) will assess physical and mental health-related quality of life (QoL) over the last four weeks, covering aspects such as physical functioning, pain, vitality, social functioning, and mental health.
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)
The SF-12 will assess physical and mental health-related quality of life (QoL) over the last four weeks, covering aspects such as physical functioning, pain, vitality, social functioning, and mental health.
Baseline (1 day before CABG surgery) and Follow Up (6 weeks after CABG surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roland von Känel

Collaborators

University of Zurich
ETH Zurich
Triemli Hospital

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC 2023-02040
  • 215033 (Other Grant/Funding Number: Swiss National Science Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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