AzTrials
AzTrials

Cardiovascular DiseasesPCDNCT06706323

Depressive Symptoms After Cardiac Surgery

An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Roland von Känel at 2 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
How many people
300 participants
Where
2 sitesSwitzerland
Study dates
25 Nov 2024to 31 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Switzerland2 sites, 2 recruiting

  • Stadtspital Zürich (City Hospital Zurich) Triemli

    Zurich, 8063

    Héctor Rodríguez, Dr. med., +41 43 253 26 87, hector.rodriguez@usz.ch

    Sinthujan Sivakumar, MSc, +41 43 253 55 94, sinthujan.sivakumar@usz.ch

    Recruiting

  • University Hospital Zurich (USZ)

    Zurich, 8091

    Héctor Rodríguez, Dr. med., +41 43 253 26 87, hector.rodriguez@usz.ch

    Sinthujan Sivakumar, MSc, +41 43 253 55 94, sinthujan.sivakumar@usz.ch

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06706323
Study groupRoleWhat they receive
Training groupFrom 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 groupFrom 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. PHQ-9 score continuous at 6 weeks post-CABG

    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.

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

  2. General Anxiety Disorder (GAD-7) score ≥10 (yes/no) at 6 weeks post-CABG

    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.

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

  3. GAD-7 score continuous at 6 weeks post-CABG

    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.

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

  4. PTSD (Post-traumatic Stress Disorder) Checklist for DSM-5 (PCL-5) score ≥33 at 6 weeks post-CABG

    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.

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

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

    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.

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

  6. Short-Form Health Survey-12 (SF-12) mental health component score at 6 weeks post-CABG

    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.

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

  7. SF-12 physical health component score at 6 weeks post-CABG

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start25 Nov 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06706323
Sponsor's protocol ID
BASEC 2023-02040
Other IDs
215033
Acronym
PCD
Status last verified
Mar 2025
First submitted
22 Nov 2024
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.2011.07.018.

    PubMed 21896369

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Roland von Känel at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roland v Känel, Prof. Dr. (+41 (0)44 255 52 51, roland.vonkaenel@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06706323, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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