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.
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 Type
OBSERVATIONAL
Enrollment
7,000
Psychotherapy: Cognitive-behavioral therapy (CBT), Internet-based cognitive-behavioral therapy (I-CBT), cognitive-behavioral therapy for insomnia (CBT-I), self-management education for heart failure, "blended" intervention; Drug treatment (cardiovascular drugs: aspirin, clopidogrel, ticagrelor, statins; psychiatric drugs: SSRIs, SNRIs, etc.);
the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China
Ningbo, Zhejiang, China
RECRUITINGseverity of depressive symptoms through CES-D
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.
Time frame: cross-sectional analyses in 2024
The Patient Health Questionnaire 9-item depression scale (PHQ-9)
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
Time frame: cross-sectional analyses in 2024
7-item Generalized Anxiety Disorder scale (GAD-7)
Total points 21. Anxiety judgment criteria: 0-4 as no, 5-9 as mild, 10-14 as moderate, 15-21 as severe.
Time frame: cross-sectional analyses in 2024
Pittsburgh sleep quality index,PSQI
Include 23 items. Total points 21. Sleep quality judgment criteria: 0-5 very good, 6-10 good, 11-15 fair, 16-21 poor.
Time frame: cross-sectional analyses in 2024
New York heart failure classification
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.
Time frame: cross-sectional analyses in 2024
Six-minute walk test
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.
Time frame: cross-sectional analyses in 2024
Major Adverse Cardiac Events
Hospitalization or mortality from Major Adverse Cardiac Events
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.