Association Between Cardiovascular Diseases and Mental Illness

Recruiting

• Conditions: Cardiovascular Diseases; Mental Disorder
• Interventions: Other: Behavioral

• Registration Number: NCT06239246
• Lead Sponsor: Ningbo No. 1 Hospital

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-12-25
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2000 hospitalized patients	Behavioral	hospitalized patients with heart diseases

Primary Outcome Measures

Name	Time	Method
severity of depressive symptoms through CES-D	cross-sectional analyses in 2024	severity of depressive symptoms through CES-D Include 20 questions, sum all points. Total points 60. Judgment critaria: ≤15 as no depressive symptoms, 16-19 as possible depressive symptoms, ≥20 as definite depressive symptoms.
7-item Generalized Anxiety Disorder scale (GAD-7)	cross-sectional analyses in 2024	Total points 21. Anxiety judgment criteria: 0-4 as no, 5-9 as mild, 10-14 as moderate, 15-21 as severe.
The Patient Health Questionnaire 9-item depression scale (PHQ-9)	cross-sectional analyses in 2024	Total points 27. depression judgment criteria: 0-4 as no, 5-9 as mild, 10-14 as moderate, 15-19 as moderate to severe, 20-27 as severe.; Framingham risk score,NYHA cardiac function classification, six-minute walk test
Six-minute walk test	cross-sectional analyses in 2024	A 6-minute walking distance of less than 150 meters indicates severe heart failure, 150-450 meters indicates moderate heart failure, and\>450 meters indicates mild heart failure.
Pittsburgh sleep quality index,PSQI	cross-sectional analyses in 2024	Include 23 items. Total points 21. Sleep quality judgment criteria: 0-5 very good, 6-10 good, 11-15 fair, 16-21 poor.
New York heart failure classification	cross-sectional analyses in 2024	Judgment criteria: Class I: patients are not limited in daily activities; Class II: patients are mildly limited in physical activity; Class III: patients are significantly limited in physical activity; Class IV: patients can not be engaged in any physical activity.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	24 months	Hospitalization or mortality from Major Adverse Cardiac Events

Trial Locations

Locations (1)

the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China; 🇨🇳 Ningbo, Zhejiang, China