Actively Recruiting

Age: 18Years - 90Years
All Genders
ID06706323

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

Led by Roland von Känel · Updated on 2025-04-01

300

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

R

Roland von Känel

Lead Sponsor

T

Triemli Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are working to develop a predictive model for clinically significant depressive symptoms (CSDS) in patients undergoing coronary artery bypass graft (CABG) surgery. CSDS affect about 30% of these patients, which is much higher than in the general population, and are linked to poorer quality of life and higher risks of illness and death. This project aims to use pre- and perioperative data to identify patients at risk for depression after surgery, helping clinicians make better prevention and management decisions. The study involves recruiting 350 patients from two hospitals undergoing elective off-pump CABG or CABG with or without valve intervention. Participants will be divided into a training group of 200 and a test group of 100 to develop and validate the prediction model. Data will include demographic, psychometric, medical, inflammation, and cardiac interoception information, analyzed using machine learning. The model will predict depression symptoms 6 weeks after surgery. Participants will be assessed before surgery and again 6 weeks post-surgery using questionnaires including the Patient Health Questionnaire (PHQ-9), General Anxiety Disorder (GAD-7) scale, PTSD Checklist (PCL-5), and Short-Form Health Survey (SF-12). The study will monitor mental and physical health changes and identify factors linked to postoperative depression. Participation involves following the study protocol and completing questionnaires at specified times, lasting through the 6-week post-surgery period.

CONDITIONS

Brief Title

Depressive Symptoms After Cardiac Surgery

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Elective off-pump coronary artery bypass graft or coronary artery bypass graft surgery, alone 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
Not Eligible

You will not qualify if you...

  • Cognitive impairment with a score of 7 or less on a modified Mini-Mental State Examination
  • Serious non-cardiac medical condition likely to cause death within 1 year, such as metastatic cancer
  • Active psychotic symptoms, substance abuse or dependence within the past 6 months, or active suicidal thoughts
  • Acute or emergency coronary artery bypass graft surgery

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo baseline assessments including demographic, psychometric, medical, inflammation, and cardiac interoception data collection approximately 1 day before coronary artery bypass graft (CABG) surgery.

1 baseline visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to discharge

Participants undergo elective off-pump coronary artery bypass graft or coronary artery bypass graft surgery, alone or combined with valve intervention.

Surgery and hospital stay (in-person)

Long-term Monitoring

Duration - 6 weeks

Participants are monitored for clinically significant depressive symptoms and other psychological outcomes 6 weeks after CABG surgery to develop predictive models based on pre- and perioperative data.

1 follow-up visit (in-person) at 6 weeks post-surgery

Trial Site Locations

Total: 2 locations

1

Stadtspital Zürich (City Hospital Zurich) Triemli

Zurich, Switzerland, 8063

Actively Recruiting

2

University Hospital Zurich (USZ)

Zurich, Switzerland, 8091

Not Yet Recruiting

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Research Team

R

Roland v Känel, Prof. Dr.

S

Sinthujan Sivakumar, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Prevalence of Depression in Coronary Artery Bypass Surgery: A Systematic Review and Meta-Analysis.

María Correa-Rodríguez, Moath Abu Ejheisheh, Nora Suleiman-Martos...

https://pubmed.ncbi.nlm.nih.gov/32225052

Moderators of the effect of psychological interventions on depression and anxiety in cardiac surgery patients: A systematic review and meta-analysis.

Cleo Protogerou, Nigel Fleeman, Kerry Dwan...

https://pubmed.ncbi.nlm.nih.gov/26319588

Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis.

Hisato Takagi, Tomo Ando, Takuya Umemoto...

https://pubmed.ncbi.nlm.nih.gov/28702898