Association Between Cardiovascular Diseases and Mental Illness

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Description

Cardiovascular diseases (CVD) are important public health concerns around the world and closely associated with the development and progression of mental illness, which in turn increases the risk of developing cardiovascular diseases. This study aimed (1) to explore the known or unknown protective and risk factors underlying this comorbidity using questionnaires; (2) to study the biomarkers (body fluid, imaging) of the participants, and to find the influence on the relationship between CVD and mental health; (3) to identify high-risk populations for mental disorders in CVD patients and to establish prediction models. (4) to establish a specialized medical database.

Study Overview

Start Date
October 1, 2022
Completion Date
December 1, 2024
Enrollment
7000
Date Posted
February 2, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China
Ningbo, Zhejiang 315000, China

Eligibility

Study Population
Individuals aged 18 to 75 years old who had normal cognition.
Minimum Age (years)
18
Maximum Age (years)
75
Eligibility Criteria
Inclusion Criteria:

Outpatient and inpatient cardiology patients, diagnosed with at least one cardiovascular disease and at least one psychological disorder
Cardiovascular diseases: ACS (STEMI, non-STEMI, unstable angina), arrhythmia (atrial fibrillation, atrioventricular block), heart failure (stable/unstable), hypertension, cardiomyopathy (hypertrophic, dilated)
Psychological disorders: structured interview diagnosed as depression, anxiety, insomnia; PHQ-9/GAD-7 score ≥ 10 points.

4.18-70 years old

Exclusion Criteria:

Clear suicidal ideation: PHQ-9 item 9 suicide ideation ≥ 3 points
Severe mental illnesses such as bipolar disorder, schizophrenia
Currently under psychotherapy
Severe cardiovascular diseases or other severe chronic life-threatening diseases
Refusal to participate
Abuse of alcoholism and drugs
Pregnant or breastfeeding
Cognitive impairment

Study Contact Info

Study Contact Name
Ruan Liemin, MD; Song Qifa, Master
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Patients with depression and cardiovascular comorbidities have a worse prognosis, a sharply reduced quality of life, and a much higher incidence of fatal CVD events, such as acute infarction, than patients with a single disease. However, due to the variety of potential causative factors and clinical manifestations, population variability, long duration of the disease, as well as neurological disorders of the exact causative mechanism still unclear, the psychological assessment among patients with cardiovascular diseases is remarkably inadequate studied.

In this study, two cohorts are established that include 2000 hospitalized patients and 5000 of the entire population. All individuals are screened for depression and anxiety. Those who score positive will be advised to enroll in this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician, cardiologist and nurse case manager, or usual care is defined for each patient. Whole blood and serum samples are obtained from all patients, which will be measured for a panel of metabolic and inflammatory indicators. Patients in both cohorts will be monitored for depression severity and duration at 6 and 12 months after enrollment. A statistical technique is applied to determine the effect size of potential risk factors.
NCTid (if applicable)
NCT06239246