Cardiovascular DiseasesNCT06239246
Association Between Cardiovascular Diseases and Mental Illness
An observational study of Cardiovascular Diseases and Mental Disorder, run by Ningbo No. 1 Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Mental Disorder
- What is being tested?
- Behavioral
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 25 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 18 to 75 years old who had normal cognition.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the first affliliated hospital of Ningbo University, Ningbo, Zhejiang Province, China
Ningbo, Zhejiang, 315000
About this study
Official title: Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Mental Disorder
- Being tested
- Behavioral
- Medical subject headings
- Cardiovascular Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralOther
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.);
| Study group | Role | What they receive |
|---|---|---|
| 2000 hospitalized patients | hospitalized patients with heart diseases Receives: Other: Behavioral | |
| 10000 community population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: cross-sectional analyses in 2024
Secondary outcomes (1)
Major Adverse Cardiac Events
Hospitalization or mortality from Major Adverse Cardiac Events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Oct 2022
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruan Liemin, Study director, Department of Psychosomatic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239246
- Sponsor's protocol ID
- 2022-R062
- Status last verified
- Jan 2024
- First submitted
- 25 Dec 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Y, Mi Y, Cui H, Song Q, Ruan L. Relationship between recurrently elevated hsCRP and adverse cardiovascular events among depressed patients in China: a time-to-event analysis. Front Cardiovasc Med. 2025 Oct 17;12:1554897. doi: 10.3389/fcvm.2025.1554897. eCollection 2025.
PubMed 41179571
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Association Between Cardiovascular Diseases and Mental Illness Considering Environmental Risk Factors
- ClinicalTrials.gov ID
- NCT06239246
- Acronym / sponsor ID
- 2022-R062
- Conditions
- Cardiovascular Diseases, Mental Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2000 hospitalized patients | – | Other: Behavioralhospitalized patients with heart diseases |
| 10000 community population | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18 to 75 years old who had normal cognition.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BehavioralPsychotherapy: 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.); | Other | 2000 hospitalized patients |
Primary outcome
severity of depressive symptoms through CES-D
Time frame: 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.
The Patient Health Questionnaire 9-item depression scale (PHQ-9)
Time frame: 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
7-item Generalized Anxiety Disorder scale (GAD-7)
Time frame: 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.
Pittsburgh sleep quality index,PSQI
Time frame: 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
Time frame: 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.
Six-minute walk test
Time frame: 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.
1 secondary outcome
Major Adverse Cardiac Events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41179571Wu Y, Mi Y, Cui H, Song Q, Ruan L. Relationship between recurrently elevated hsCRP and adverse cardiovascular events among depressed patients in China: a time-to-event analysis. Front Cardiovasc Med. 2025 Oct 17;12:1554897. doi: 10.3389/fcvm.2025.1554897. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruan Liemin study director
Department of Psychosomatic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Mental Disorder, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of depressive symptoms through CES-D (time frame: cross-sectional analyses in 2024). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.