Investigating cardiac risk markers in depressed patients with coronary heart disease
Fatigue, Anhedonia and Cardiac Prognostic Markers in Depressed Patients With Coronary Heart Disease
This study looks at how depression affects heart health in people with coronary heart disease to see if certain markers can help improve treatment and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT04682769 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between depression and cardiac risk markers in patients with coronary heart disease (CHD). It focuses on identifying risk markers associated with persistent depression symptoms despite treatment, such as fatigue and anhedonia. The study will analyze various factors, including thyroid hormone levels and heart rate variability, to understand their impact on depression treatment response. The findings are expected to inform the development of more effective interventions to improve both mental health and survival rates in CHD patients.
Who should consider this trial
Good fit: Ideal candidates include patients with documented coronary heart disease who also meet the criteria for a depressive disorder and are on a stable medication regimen.
Not a fit: Patients with thyroid disease, severe cognitive impairment, or major psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for depression in patients with coronary heart disease, potentially enhancing their overall survival.
How similar studies have performed: Previous studies have indicated a correlation between depression and cardiac outcomes, but this specific approach to identifying risk markers in CHD patients with persistent depression symptoms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients seen at the Washington University Medical Center with coronary heart disease (CHD) documented by coronary angiography or history of acute coronary syndrome (ACS). * On a stable medication regimen (only minor changes in drug or dosage in last 30 days) are eligible for recruitment. * Meet the diagnostic criteria for a depressive disorder, score ≥ 14 on the Beck Depression Inventory (BDI-II), and not meet any exclusion criteria. Exclusion Criteria: * Thyroid disease or thyroid medications. * Moderate to severe cognitive impairment. * Major psychiatric comorbidities. * Taking antidepressants other than a selective serotonin reuptake inhibitor (SSRI). * Suicidal features. * Current substance abuse. * New York Heart Association (NYHA) class III or higher or a recent (\<3 months) acute coronary syndrome (ACS), coronary artery bypass graft surgery, cardiac hospitalization, or cardiac-related emergency department visit. * Advanced malignancy, a disability that would prevent compliance with the study protocol, or physician or patient refusal.
Where this trial is running
Saint Louis, Missouri
- Washington University — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth E Freedland, PhD — Washington University School of Medicine
- Study coordinator: Patricia A Herzing, RN
- Email: herzingp@wustl.edu
- Phone: 314-286-1360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.