Clinical trial NCT06239246: Association Between Cardiovascular Diseases and Mental Illness
Official title: Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Mental Disorder
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18 to 75 years old who had normal cognition.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

4．18-70 years old

Exclusion Criteria:

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

Primary outcomes:
measure: severity of depressive symptoms through CES-D
timeFrame: cross-sectional analyses in 2024
measure: The Patient Health Questionnaire 9-item depression scale (PHQ-9)
timeFrame: cross-sectional analyses in 2024
measure: 7-item Generalized Anxiety Disorder scale (GAD-7)
timeFrame: cross-sectional analyses in 2024
measure: Pittsburgh sleep quality index,PSQI
timeFrame: cross-sectional analyses in 2024
measure: New York heart failure classification
timeFrame: cross-sectional analyses in 2024
measure: Six-minute walk test
timeFrame: cross-sectional analyses in 2024
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Ningbo
country: China
facility: the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China
state: Zhejiang
Study officials:
affiliation: Department of Psychosomatic Medicine
name: Ruan Liemin
role: STUDY_DIRECTOR
References: