Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862

NCT04682769 | Completed

• 1 other identifier: R01HL147862
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• This is our primary measure of depression severity.

  Beck Depression Inventory (BDI-II) scale 0-63; higher score indicates a more severe depression

  baseline contact

Study Arms (1)

Patients with medically stable coronary heart disease and Depressive Disorder

Other: Other

Interventions

Other OTHER

Patients with Coronary Heart Disease and Depressive Disorder are receiving routine treatment by their physician.

Patients with medically stable coronary heart disease and Depressive Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Coronary Disease and Depressive Disorder

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Coronary Disease; Depression

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Kenneth E Freedland, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 24, 2020
• Study Start: December 1, 2020
• Primary Completion: January 25, 2025
• Study Completion: May 31, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The dataset is expected to be finalized in mid- to late-2025.
• Access Criteria: Affiliation with a recognized research institution

Locations

US (1)