Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- severity of depressive symptoms through CES-D
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
2000 hospitalized patients
hospitalized patients with heart diseases
干预措施: Behavioral (Other)
10000 community population
结局指标
主要结局
severity of depressive symptoms through CES-D
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Major Adverse Cardiac Events(24 months)