Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862 (NCT04682769) | Clinical Trial Compass
CompletedNot Applicable
Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862
United States175 participantsStarted 2020-12-01
Plain-language summary
Depression doubles the risk of death in patients with coronary heart disease (CHD), but so far, there is insufficient evidence that we can reduce the risk of death by treating depression. This study will investigate the cardiac risk markers that are associated with depression symptoms that remain despite treatment, and identify potential targets for their treatment. The results of the study will inform the development of more effective interventions to improve both depression and survival in patients with CHD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
This is our primary measure of depression severity.