Cardio-cerebral Vascular EventsNCT06070805
Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in MHD Patients
An observational study of Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Depression is a common psychiatric disorder in patients on maintenance hemodialysis (MHD). It may contribute to poor prognosis in a number of ways, including its effect on platelet function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardio-cerebral Vascular Events, Arteriovenous Fistula Dysfunction
- What is being tested?
- depression
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 May 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing maintenance hemodialysis were recruited from the First Affiliated Hospital of Chongqing Medical University in China.
Who may be able to join
- Patients had undergone dialysis treatment for more than 3 months, and their medical status was stable at the time of enrollment, with an expected survival period of more than 1 year
Who cannot join
- (1) with communication disorders or mental illness other than depression; (2) a combination of cirrhosis, lymphoma, thrombocytopenic purpura, or other diseases that significantly affect platelet function; (3) complicated with malignant tumors, tuberculosis, severe heart failure, and unstable medical conditions; (4) inability or unwillingness to cooperate with researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: The Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in Hemodialysis Patients: A Single Center and Real-world Study
Depression is a common psychiatric disorder in patients on maintenance hemodialysis (MHD). It may contribute to poor prognosis in a number of ways, including its effect on platelet function. We aimed to investigate the impact and underlying mechanisms of depression on the occurrence of cardio-cerebral vascular events (CCVE) and dysfunction of arteriovenous fistula (DAVF) in MHD patients.
In this study, MHD patients were recruited and divided into depression and non-depression groups using the Hamilton Depression Scale (HAMD) in this prospective cohort study. Their clinical and laboratory indicators were collected and the occurrence of CCVE and DAVF were recorded through clinical follow-up, and analyzed, and the differences and possible influencing factors of CCVE and DAVF occurrence were assessed between the two groups of patients.
- Being tested
- depression
- Keywords
- maintenance hemodialysis patients, depression, cardio-cerebral vascular events, arteriovenous fistula dysfunction, platelet
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depressionOther
The score of Hamilton Rating Scale for Depression (HAMD) is ≥8
| Study group | Role | What they receive |
|---|---|---|
| Non-depression group | The Hamilton Rating Scale for Depression (HAMD) will be applied to assess the depressive status of all enrolled patients. This scale consists of 24 survey items, each with a score of 0-4. Patients will be assigned to the nondepression group if their HAMD score was <8. Receives: Other: depression | |
| Depression group | Patients will be assigned to the depression group if their score was ≥8. Receives: Other: depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardio-cerebral vascular events (CCVE)
CCVEs were defined as the first occurrence of angina pectoris, myocardial infarction, episodes of heart failure requiring clinical intervention, arrhythmic episodes with clinically significant symptoms, transient ischemic attack, cerebral infarction, and cerebral hemorrhage during the observational period.
Measured: 1 year
dysfunction of arteriovenous fistula (DAVF)
DAVF was diagnosed if a patient presented with any one or more of the following conditions that render his or her AVF unsatisfactory for effective hemodialysis: (1) loss of AVF murmur on clinical auscultation; (2) notable weakening or disappearance of pulsation in AVF; (3) echography showing interruption of blood flow, thrombosis within the internal fistula, or stenosis of the venous outflow tract at or near the anastomotic site; or (4) maximum blood flow <200 mL/min in AVF during dialysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Feb 2022
- Primary completion8 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-cerebral Vascular EventsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- 286 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfeng Xia, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Yunfeng Xia, Dr, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070805
- Sponsor's protocol ID
- 1st ChongqingMU
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact and Mechanism of Depression on Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction in Hemodialysis Patients: A Single Center and Real-world Study
- ClinicalTrials.gov ID
- NCT06070805
- Acronym / sponsor ID
- 1st ChongqingMU
- Keywords
- maintenance hemodialysis patients, depression, cardio-cerebral vascular events, arteriovenous fistula dysfunction, platelet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 8 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 6 Oct 2023 (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.
Depression is a common psychiatric disorder in patients on maintenance hemodialysis (MHD). It may contribute to poor prognosis in a number of ways, including its effect on platelet function. We aimed to investigate the impact and underlying mechanisms of depression on the occurrence of cardio-cerebral vascular events (CCVE) and dysfunction of arteriovenous fistula (DAVF) in MHD patients.
In this study, MHD patients were recruited and divided into depression and non-depression groups using the Hamilton Depression Scale (HAMD) in this prospective cohort study. Their clinical and laboratory indicators were collected and the occurrence of CCVE and DAVF were recorded through clinical follow-up, and analyzed, and the differences and possible influencing factors of CCVE and DAVF occurrence were assessed between the two groups of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-depression group | – | Other: depressionThe Hamilton Rating Scale for Depression (HAMD) will be applied to assess the depressive status of all enrolled patients. This scale consists of 24 survey items, each with a score of 0-4. Patients will be assigned to the nondepression group if their HAMD score was <8. |
| Depression group | – | Other: depressionPatients will be assigned to the depression group if their score was ≥8. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing maintenance hemodialysis were recruited from the First Affiliated Hospital of Chongqing Medical University in China.
Key inclusion criteria (1 listed)
- Patients had undergone dialysis treatment for more than 3 months, and their medical status was stable at the time of enrollment, with an expected survival period of more than 1 year
Key exclusion criteria (1 listed)
- (1) with communication disorders or mental illness other than depression; (2) a combination of cirrhosis, lymphoma, thrombocytopenic purpura, or other diseases that significantly affect platelet function; (3) complicated with malignant tumors, tuberculosis, severe heart failure, and unstable medical conditions; (4) inability or unwillingness to cooperate with researchers.
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 |
|---|---|---|
| depressionThe score of Hamilton Rating Scale for Depression (HAMD) is ≥8 | Other | Depression group, Non-depression group |
Primary outcome
cardio-cerebral vascular events (CCVE)
Time frame: 1 year
CCVEs were defined as the first occurrence of angina pectoris, myocardial infarction, episodes of heart failure requiring clinical intervention, arrhythmic episodes with clinically significant symptoms, transient ischemic attack, cerebral infarction, and cerebral hemorrhage during the observational period.
dysfunction of arteriovenous fistula (DAVF)
Time frame: 1 year
DAVF was diagnosed if a patient presented with any one or more of the following conditions that render his or her AVF unsatisfactory for effective hemodialysis: (1) loss of AVF murmur on clinical auscultation; (2) notable weakening or disappearance of pulsation in AVF; (3) echography showing interruption of blood flow, thrombosis within the internal fistula, or stenosis of the venous outflow tract at or near the anastomotic site; or (4) maximum blood flow <200 mL/min in AVF during dialysis.
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 6 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Yunfeng Xia, Dr study director
First Affiliated Hospital of Chongqing Medical University
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 Cardio-cerebral Vascular Events and Arteriovenous Fistula Dysfunction, run by First Affiliated Hospital of Chongqing Medical University 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 1 inclusion and 1 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 6 Oct 2023. 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?
cardio-cerebral vascular events (CCVE) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.