An observational study in Depression and CVD, sponsored by First Affiliated Hospital of Harbin Medical University. Not yet recruiting at 1 site in China. Open to participants aged Up to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by First Affiliated Hospital of Harbin Medical University · Observational
Cardiovascular disease is the main cause of death in the world, accounting for 32% of all deaths. In 2019, the number of people suffering from cardiovascular diseases in the world was about 523 million, of which about 18.6 million died of cardiovascular diseases. Although great progress has been made in reducing the burden of cardiovascular diseases by controlling typical risk factors, there is still a lack of effective intervention means and measures for cardiovascular diseases induced by atypical risk factors (such as environmental pollution, obesity and anxiety and depression).
Depression is a health problem as common as cardiovascular disease, and it has been proved to be an important risk factor of cardiovascular disease. Previous studies have shown that depression is related to the increased risk of subsequent cardiovascular events, including myocardial infarction, angina pectoris, stroke and cardiovascular mortality. The risk of cardiovascular disease in patients with major depression is about 72% higher than that in healthy control group.
Previous studies have shown that compared with healthy people, the intestinal microbial composition of patients with major depression, especially the microbial diversity and the relative abundance of specific bacterial groups, has changed significantly. Many studies have also confirmed that dysbacteriosis may be an important cause of MDD, and with the passage of time, the pathological changes caused by MDD will further destroy the intestinal environment and lead to dysbacteriosis. In addition, intestinal microflora can also produce a variety of important mediators, such as metabolites produced by bacterial fermentation of food, host molecules modified by bacteria (bile acids, etc.) or direct products of bacteria, which also play an important role in the pathogenesis of MDD. In recent years, both population studies and animal experiments have found that the changes in the composition and function of intestinal flora (that is, the imbalance of intestinal microbial flora) will accelerate the occurrence and development of cardiovascular diseases. Intestinal flora will metabolize the food ingested by the host into a series of metabolites, including trimethylamine oxide, short-chain fatty acids, secondary bile acids and indole sulfate, etc. These metabolites will affect the physiological process of the host by activating various signal pathways, thus affecting the occurrence and development of cardiovascular diseases (such as coronary heart disease, hypertension, arrhythmia and heart failure).
All the above results suggest that intestinal flora and its metabolites play an important role in promoting the occurrence and development of cardiovascular diseases in depression, but its internal mechanism is not completely clear. Therefore, it is of great significance to deeply explore the pathophysiological mechanism of depression on cardiovascular diseases for guiding the prevention and treatment of cardiovascular diseases.
A total of 300 people were enrolled in this study, which were divided into healthy control group, depression group and depression combined with cardiovascular disease group, with 100 cases in each group. Samples of patients' feces, urine peripheral blood and oral secretions were collected and analyzed by multi-omics. Subsequently, after 6 months, 1 year, 2 years and 5 years after discharge, the clinical prognosis of the patients was obtained and recorded.
The purpose of this study is to discover and deeply explore the pathophysiological mechanism of depression on common cardiovascular diseases (coronary heart disease, hypertension, arrhythmia or heart failure) through the research methods of 16S rDNA sequencing, metagenome sequencing and metabonomics, so as to provide theoretical basis for comprehensive treatment of cardiovascular diseases caused by depression, and at the same time provide potential biomarkers and prevention targets for cardiovascular diseases caused by depression.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 300 is above the median of 175 across 1,257 observational studies indexed under Depression.
Browse Depression studies →First Affiliated Hospital of Harbin Medical University is the lead sponsor of 74 studies on the registry; 11 are open to participants now.
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Samples of feces, urine and peripheral blood were collected from healthy control group, depression group and depression combined with cardiovascular disease group, and were analyzed by multi-omics. Subsequently, the patients were followed up in the outpatient clinic at 6 months, 1 year, 2 years and 5 years after discharge, and the clinical prognosis details of the patients were obtained and recorded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1) Good health and no gastrointestinal diseases; 2) No previous history of mental illness; 2) No previous history of cardiovascular disease;
1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2. Patients with first-episode depression; 3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks.
1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2. Patients with first-episode depression; 3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks. 4. There is definite clinical evidence of heart failure, coronary heart disease, hypertension or arrhythmia.
data of analysis of multi-omics
Samples of feces, urine and peripheral blood were collected from healthy control group, depression group and depression combined with cardiovascular disease group, and were analyzed by multi-omics. Subsequently, the patients were followed up in the outpatient clinic at 6 months, 1 year, 2 years and 5 years after discharge, and the clinical prognosis details of the patients were obtained and recorded.
Time frame: From enrollment to the end of five-year follow-up
Plan to share: Undecided
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First Affiliated Hospital of Harbin Medical University