Association Between Cardiovascular Diseases and Mental Illness

Cardiovascular Diseases Clinical Trial

Official title:

Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239246
• Other study ID #: 2022-R062
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Ningbo No. 1 Hospital
• Contact: Ruan Liemin, MD
• Phone: 0086057487085111
• Email: lmruan[@]tom.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Mental Disorder
• Mental Disorders

Intervention

Other:
• Behavioral
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.);

Locations

Country	Name	City	State
China	the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity 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.	cross-sectional analyses in 2024
Primary	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	cross-sectional analyses in 2024
Primary	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.	cross-sectional analyses in 2024
Primary	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.	cross-sectional analyses in 2024
Primary	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.	cross-sectional analyses in 2024
Primary	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.	cross-sectional analyses in 2024
Secondary	Major Adverse Cardiac Events	Hospitalization or mortality from Major Adverse Cardiac Events	24 months