Nervous System DiseasesNCT06099496
Association Analysis of Cardiovascular and Nervous System Diseases and Intestinal Microbiome Based on Multi-omics Big Data and Related Applications
An observational study of Nervous System Diseases and Cardiovascular and Cerebrovascular Diseases, run by Tao Xin at 1 site in China.
Trial summary
Research purpose 1. Combined with multi-omics data and advanced data mining methods, we explored the pathogenesis and potential application pathway of intestinal microbiome mediated by specific cardiovascular diseases (such as idiopathic ventricular tachycardia, stenosis after coronary artery stenting injury, etc.)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases, Cardiovascular and Cerebrovascular Diseases
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Apr 2026
- How long will I take part?
- 3 Years
- 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: outpatients from Shandong Province Qianfoshan Hospital.Based on electrocardiogram, blood test or B-ultrasonography and other examination methods, combined with clinical manifestations, patients judged by professional physicians as meeting the inclusion criteria of this experimental protocol will be included in the study cohort for study.
Who may be able to join
- Idiopathic ventricular tachycardia and frequent ventricular premature were recorded by routine 12-lead electrocardiogram or 24-hour holter electrocardiogram. It can meet the clinical diagnostic criteria of idiopathic speed and frequent ventricular premature.
- 18 years ≤ age ≤75 years.
- Moyamoya disease was confirmed by imaging examination.
- 18 years ≤ age ≤75 years.
- Imaging diagnosis confirmed no moyamoya disease.
- 18 years ≤ age ≤75 years.
- Carotid atherosclerosis was confirmed by ultrasound, CTA and other imaging examinations.
- 18 years ≤ age ≤75 years.
Who cannot join
- Patients with coronary heart disease, myocardial infarction, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other organic heart disease.
- Use of antibiotic drugs within 45 days.
- Case control inclusion criteria for idiopathic ventricular tachycardia:
- Routine 12-lead ECG or 24-hour holter ECG did not find idiopathic ventricular tachycardia and frequent ventricular premature.
- 18 years ≤ age ≤75 years.
- Case-control exclusion criteria for idiopathic ventricular tachycardia:
Show all 31Show fewer
- Patients with coronary heart disease, myocardial infarction, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other organic heart disease.
- Use of antibiotic drugs within 45 days.
- Inclusion criteria of postoperative coronary artery stenosis injury cases:
- Patients with confirmed coronary heart disease or history of coronary heart disease, after interventional treatment, stent implantation, and regular CTA review.
- 18 years ≤ age ≤75 years.
- Exclusion criteria for postoperative coronary artery stenosis injury cases:
- CTA found no vascular restenosis.
- Use of antibiotic drugs within 45 days.
- Inclusion criteria for case control of postoperative vascular stenosis injury in coronary heart disease:
- Confirmed coronary heart disease or history of coronary heart disease, after interventional treatment, stent implantation, CTA examination did not find restenosis of blood vessels.
- 18 years ≤ age ≤75 years.
- Case-control exclusion criteria for postoperative vascular stenosis injury of coronary heart disease:
- Use of antibiotic drugs within 45 days.
- Previous history of vascular surgery or trauma
- Use of antibiotic drugs within 45 days.
- Previous history of vascular surgery or trauma.
- Use of antibiotic drugs within 45 days.
- Previous history of carotid vascular surgery or trauma.
- Use of antibiotic drugs within 45 days.
- Inclusion criteria for carotid atherosclerosis case control:
- Carotid ultrasound showed no atherosclerosis.
- 18 years ≤ age ≤75 years.
- Carotid atherosclerosis case-control exclusion criteria:
- Previous history of carotid vascular surgery or trauma.
- Use of antibiotic drugs within 45 days.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan
Xin Tao, Director of Neurosurgery, 18888376796, drxintao@yeah.net
About this study
Research purpose
- Combined with multi-omics data and advanced data mining methods, we explored the pathogenesis and potential application pathway of intestinal microbiome mediated by specific cardiovascular diseases (such as idiopathic ventricular tachycardia, stenosis after coronary artery stenting injury, etc.) and nervous system diseases (such as carotid atherosclerosis, moyamoya disease, etc.).
- The secondary goal of this study is the construction of risk prediction model. Based on the pathogenesis identified by multi-omics association analysis, detailed dietary information and clinical information related to cardiovascular and nervous system diseases, the risk of cardiovascular and nervous system diseases was assessed and the disease risk model was constructed.
- Based on the key genes and microorganisms excavated, disease-related machine learning models can be built, and models can be built to prevent and treat diseases.
Read more
Research background Cardiovascular and nervous system diseases such as arrhythmias (atrial fibrillation, ventricular tachycardia, ventricular fibrillation, postoperative vascular stenosis injury, etc.), heart failure, atherosclerosis (coronary heart disease, stroke, peripheral vascular disease, carotid atherosclerosis, etc.), epilepsy, moyamoya disease, etc., are currently leading to the main diseases affecting the health and death of residents in China.
Through the unremitting efforts of many scientists, the research on the association between intestinal flora and cardiovascular diseases (ventricular tachycardia/atrial fibrillation, carotid atherosclerosis, etc.) and nervous system diseases (Parkinson's disease, epilepsy, carotid atherosclerosis, etc.) has made breakthrough progress. However, the study of gut microbiota is still in its infancy, and it is not possible to deeply understand the complex regulatory processes between heart disease and nervous system diseases and gut microbiota, involving a large number of host genes, host metabolites, and associated bacteria and bacteria-related metabolites. Based on multi-omics data, the data integration method combined with machine learning analyzes the connection between cardiovascular and nervous system and gut microbes, helping to deepen the research on the mechanism related to heart disease and nervous system under the regulation of gut microbes and providing new ideas for the prevention and treatment of related diseases. This study will also promote the implementation of clinical interventions with precise flora and provide new ideas for the treatment of cardiovascular diseases and neurological diseases.
Read the detailed description
A microbial ecosystem is a complex community of interacting bacteria. The potential role of intestinal flora in human health has attracted extensive attention. Imbalances in the gut microbiome have been implicated in a variety of chronic diseases. Cardiovascular diseases (CVDs) are the leading cause of morbidity worldwide and are influenced by both genetic and environmental factors. Recent advances have provided scientific evidence that cardiovascular disease may also be attributable to gut microbiota. In many literatures, we have found complex interactions between microorganisms, their metabolites, and potential impacts on the development and progression of cardiovascular disease. The use of intestinal flora in the treatment of cardiovascular diseases is the latest research direction. Gut microbes are likely to be used in the clinical treatment of cardiovascular diseases in the near future.
Gut flora plays an important role in human health and disease transformation. It not only participates in many physiological processes of the host, but also affects the function of the central nervous system (CNS) through the activity of the microbiota - gut - brain axis, which may be closely related to neurotransmitter, immune, endocrine and metabolite pathways. When the intestinal flora is dysfunctional, it can affect the occurrence and development of CNS diseases such as cerebral ischemia, Parkinson's disease, Alzheimer's disease, multiple sclerosis, hepatic encephalopathy and mental disorders. Fecal microbial transplantation, exercise training, acupuncture and massage and other therapies can improve intestinal flora disorders, and are expected to become effective measures to treat and prevent some nervous system diseases.
- Subject selection basis Based on electrocardiogram, blood test or B-ultrasonography and other examination methods, combined with clinical manifestations, patients judged by professional physicians as meeting the inclusion criteria of this experimental protocol will be included in the study cohort for study.
- Dosage selection/administration plan/dosage adjustment basis This study did not involve intervention experiments, and there was no dose selection/dosing regimen/dose adjustment.
- Basis for destination selection This experiment is not an intervention experiment, so the end point of this experiment is chosen after the subjects are diagnosed with related diseases or the control group, and the end point is taken after the completion of sampling.
- Risk and benefit basis For patients with specific cardiovascular and cerebrovascular diseases, the benefits of this trial far outweigh the risks. This experiment will collect fecal samples in vitro, which is a non-invasive sample collection, which will not cause trauma to patients and has high safety. This project will also collect peripheral blood samples from patients for study. The process of collecting blood samples may involve pain and other reactions, but the operations involved in this study are all carried out by experienced nurses and nurses to minimize such risks.
This experiment will contribute to the research of cardiovascular and nervous system-related diseases. By elucidating the molecular mechanism of intestinal microorganisms regulating cardiovascular and nervous system diseases, disease-related genes and biomarkers can be found, promoting the accurate diagnosis of diseases, providing targets for the precise treatment and prevention of diseases, and providing targeted regulation of the structure and metabolite composition of microorganisms. Prevention and treatment of related diseases.
Research content
- Test population This project plans to use multi-omics big data (host genome, transcriptome, metabolome, metagenomic and metabetomic data), combined with cardiovascular disease cohort (idiopathic ventricular tachycardia, restenosis after coronary artery stenting injury) and nervous system disease cohort (carotid atherosclerosis, Moyamoya disease), and use machine learning to integrate data from different omics. To delve deeper into the mechanisms of cardiovascular disease and the role of gut microbes in it. The entire process is expected to involve nearly 500 sequencing objects, different omics data (totaling tens of thousands of samples), and yield a total of hundreds of terabytes of omics data.
- Sample size calculation Through literature research and clinical big data analysis, reliable conclusions can be obtained with an experimental cohort of more than 200 people and a control cohort. So the experimental data were selected from a disease cohort of 250 people and a control cohort of 240 people.
- Specific research content First, data, including blood and stool samples, need to be collected from cohorts of patients with cardiovascular and neurological diseases and from healthy people. Based on the amount of data in published articles and the statistical adjustment results of the trial, an estimated disease cohort of 250 people and a healthy control cohort of 240 people are expected. At the same time, detailed sample information (including physical examination data and phenotypic data such as diet data) was recorded so that multi-omics data could be combined to gain insight into factors affecting cardiovascular disease.
Second, the genome and transcriptome of the collected blood samples were sequenced. For fecal samples, metagenomic sequencing and metometabolic and proteomic sequencing were performed.
Thirdly, for multi-omics data processing, data processing of sequenced genes, transcripts, metagenomes and metabetomes is carried out, and combined with disease cohort, key genes potentially causing corresponding diseases and corresponding microbial data are selected.
Fourthly, for the data analysis step, based on the cohort of cardiovascular diseases and neurological diseases, the association analysis of these candidate host genes and bacteria is conducted by using machine learning methods, and the construction and interpretation of relevant pathways are carried out in combination with previous studies. Mechanisms and pathways rise to the recognition of patterns for the construction of predictive models for early disease prevention and disease diagnosis.
- Medical subject headings
- Nervous System Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease group | Collect data from patients with cardiovascular and neurological diseases, including blood and stool samples. Genome and transcriptome sequencing was performed on the collected blood samples. For fecal samples, metagenomic sequencing and metometabolic and proteomic sequencing were performed. | |
| Healthy control group | Collect data from healthy people, including blood and stool samples. Genome and transcriptome sequencing was performed on the collected blood samples. For fecal samples, metagenomic sequencing and metometabolic and proteomic sequencing were performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool sampling
① Sampling should be taken at the non-eating stage between 6am and 9am Before sampling, stool must be emptied into a clean and dry urinal or container containing filter paper. Note: Urine should not be mixed into the container.
② Use a small spoon in the sampler to collect feces. Note: In order to prevent contamination of the stool surface, gently peel the surface with a sampling spoon, and sample the inside of the stool, placing it in an average of three feces tubes.
③ After sampling, close the cover of the collector and mark the name and sampling time on the collector with a pen. Store at room temperature for 1 day, long-term storage at -80℃.
Note: The sampler should not take antibiotics or other drugs for 45 days.
Measured: One month after the patient is clinically diagnosed with the above disease
Blood collection
① Collect 5-10ml blood of the subject, centrifuge, collect serum and plasma, temporarily do not test, can be immediately frozen at low temperature, the lower the temperature is better, if not repeated freezing and thawing in the middle, can be stored for one month below -20℃, can be stored for three months below -80℃.
② Citrate anticoagulant and plasma collection: Sodium citrate acts as an anticoagulant by acting on calcium ion chelation in blood samples, recommended by the National Committee for Standardization of Clinical Laboratories (NCCLS) is 3.2% or 3.8%, and the anticoagulant to blood ratio is 1: 9, mainly used in the fibrinolytic system (prothrombin time, thrombin time, activated partial thrombin time, fibrinogen). When taking blood, attention should be paid to taking enough blood to ensure the accuracy of the test results, and the blood should be gently reversed and mixed 5-8 times immediately after taking blood.
Measured: One month after the patient is clinically diagnosed with the above disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Apr 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nervous System 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
- 490 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tao Xin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Xin, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099496
- Sponsor's protocol ID
- YXLL-KY-2023(037)
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jin M, Qian Z, Yin J, Xu W, Zhou X. The role of intestinal microbiota in cardiovascular disease. J Cell Mol Med. 2019 Apr;23(4):2343-2350. doi: 10.1111/jcmm.14195. Epub 2019 Feb 3.
PubMed 30712327Jia Q, Xie Y, Lu C, Zhang A, Lu Y, Lv S, Zhang J. Endocrine organs of cardiovascular diseases: Gut microbiota. J Cell Mol Med. 2019 Apr;23(4):2314-2323. doi: 10.1111/jcmm.14164. Epub 2019 Jan 27.
PubMed 30688023Yan Q, Zhai W, Yang C, Li Z, Mao L, Zhao M, Wu X. The Relationship among Physical Activity, Intestinal Flora, and Cardiovascular Disease. Cardiovasc Ther. 2021 Oct 12;2021:3364418. doi: 10.1155/2021/3364418. eCollection 2021.
PubMed 34729078Zou Y, Song X, Liu N, Sun W, Liu B. Intestinal Flora: A Potential New Regulator of Cardiovascular Disease. Aging Dis. 2022 Jun 1;13(3):753-772. doi: 10.14336/AD.2021.1022. eCollection 2022 Jun.
PubMed 35656118
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Analysis of Cardiovascular and Nervous System Diseases and Intestinal Microbiome Based on Multi-omics Big Data and Related Applications
- ClinicalTrials.gov ID
- NCT06099496
- Acronym / sponsor ID
- YXLL-KY-2023(037)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Tao XinUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 25 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.
Research purpose
- Combined with multi-omics data and advanced data mining methods, we explored the pathogenesis and potential application pathway of intestinal microbiome mediated by specific cardiovascular diseases (such as idiopathic ventricular tachycardia, stenosis after coronary artery stenting injury, etc.) and nervous system diseases (such as carotid atherosclerosis, moyamoya disease, etc.).
- The secondary goal of this study is the construction of risk prediction model. Based on the pathogenesis identified by multi-omics association analysis, detailed dietary information and clinical information related to cardiovascular and nervous system diseases, the risk of cardiovascular and nervous system diseases was assessed and the disease risk model was constructed.
- Based on the key genes and microorganisms excavated, disease-related machine learning models can be built, and models can be built to prevent and treat diseases.
Research background Cardiovascular and nervous system diseases such as arrhythmias (atrial fibrillation, ventricular tachycardia, ventricular fibrillation, postoperative vascular stenosis injury, etc.), heart failure, atherosclerosis (coronary heart disease, stroke, peripheral vascular disease, carotid atherosclerosis, etc.), epilepsy, moyamoya disease, etc., are currently leading to the main diseases affecting the health and death of residents in China.
Through the unremitting efforts of many scientists, the research on the association between intestinal flora and cardiovascular diseases (ventricular tachycardia/atrial fibrillation, carotid atherosclerosis, etc.) and nervous system diseases (Parkinson's disease, epilepsy, carotid atherosclerosis, etc.) has made breakthrough progress. However, the study of gut microbiota is still in its infancy, and it is not possible to deeply understand the complex regulatory processes between heart disease and nervous system diseases and gut microbiota, involving a large number of host genes, host metabolites, and associated bacteria and bacteria-related metabolites. Based on multi-omics data, the data integration method combined with machine learning analyzes the connection between cardiovascular and nervous system and gut microbes, helping to deepen the research on the mechanism related to heart disease and nervous system under the regulation of gut microbes and providing new ideas for the prevention and treatment of related diseases. This study will also promote the implementation of clinical interventions with precise flora and provide new ideas for the treatment of cardiovascular diseases and neurological diseases.
Detailed description
A microbial ecosystem is a complex community of interacting bacteria. The potential role of intestinal flora in human health has attracted extensive attention. Imbalances in the gut microbiome have been implicated in a variety of chronic diseases. Cardiovascular diseases (CVDs) are the leading cause of morbidity worldwide and are influenced by both genetic and environmental factors. Recent advances have provided scientific evidence that cardiovascular disease may also be attributable to gut microbiota. In many literatures, we have found complex interactions between microorganisms, their metabolites, and potential impacts on the development and progression of cardiovascular disease. The use of intestinal flora in the treatment of cardiovascular diseases is the latest research direction. Gut microbes are likely to be used in the clinical treatment of cardiovascular diseases in the near future.
Gut flora plays an important role in human health and disease transformation. It not only participates in many physiological processes of the host, but also affects the function of the central nervous system (CNS) through the activity of the microbiota - gut - brain axis, which may be closely related to neurotransmitter, immune, endocrine and metabolite pathways. When the intestinal flora is dysfunctional, it can affect the occurrence and development of CNS diseases such as cerebral ischemia, Parkinson's disease, Alzheimer's disease, multiple sclerosis, hepatic encephalopathy and mental disorders. Fecal microbial transplantation, exercise training, acupuncture and massage and other therapies can improve intestinal flora disorders, and are expected to become effective measures to treat and prevent some nervous system diseases.
- Subject selection basis Based on electrocardiogram, blood test or B-ultrasonography and other examination methods, combined with clinical manifestations, patients judged by professional physicians as meeting the inclusion criteria of this experimental protocol will be included in the study cohort for study.
- Dosage selection/administration plan/dosage adjustment basis This study did not involve intervention experiments, and there was no dose selection/dosing regimen/dose adjustment.
- Basis for destination selection This experiment is not an intervention experiment, so the end point of this experiment is chosen after the subjects are diagnosed with related diseases or the control group, and the end point is taken after the completion of sampling.
- Risk and benefit basis For patients with specific cardiovascular and cerebrovascular diseases, the benefits of this trial far outweigh the risks. This experiment will collect fecal samples in vitro, which is a non-invasive sample collection, which will not cause trauma to patients and has high safety. This project will also collect peripheral blood samples from patients for study. The process of collecting blood samples may involve pain and other reactions, but the operations involved in this study are all carried out by experienced nurses and nurses to minimize such risks.
This experiment will contribute to the research of cardiovascular and nervous system-related diseases. By elucidating the molecular mechanism of intestinal microorganisms regulating cardiovascular and nervous system diseases, disease-related genes and biomarkers can be found, promoting the accurate diagnosis of diseases, providing targets for the precise treatment and prevention of diseases, and providing targeted regulation of the structure and metabolite composition of microorganisms. Prevention and treatment of related diseases.
Research content
- Test population This project plans to use multi-omics big data (host genome, transcriptome, metabolome, metagenomic and metabetomic data), combined with cardiovascular disease cohort (idiopathic ventricular tachycardia, restenosis after coronary artery stenting injury) and nervous system disease cohort (carotid atherosclerosis, Moyamoya disease), and use machine learning to integrate data from different omics. To delve deeper into the mechanisms of cardiovascular disease and the role of gut microbes in it. The entire process is expected to involve nearly 500 sequencing objects, different omics data (totaling tens of thousands of samples), and yield a total of hundreds of terabytes of omics data.
- Sample size calculation Through literature research and clinical big data analysis, reliable conclusions can be obtained with an experimental cohort of more than 200 people and a control cohort. So the experimental data were selected from a disease cohort of 250 people and a control cohort of 240 people.
- Specific research content First, data, including blood and stool samples, need to be collected from cohorts of patients with cardiovascular and neurological diseases and from healthy people. Based on the amount of data in published articles and the statistical adjustment results of the trial, an estimated disease cohort of 250 people and a healthy control cohort of 240 people are expected. At the same time, detailed sample information (including physical examination data and phenotypic data such as diet data) was recorded so that multi-omics data could be combined to gain insight into factors affecting cardiovascular disease.
Second, the genome and transcriptome of the collected blood samples were sequenced. For fecal samples, metagenomic sequencing and metometabolic and proteomic sequencing were performed.
Thirdly, for multi-omics data processing, data processing of sequenced genes, transcripts, metagenomes and metabetomes is carried out, and combined with disease cohort, key genes potentially causing corresponding diseases and corresponding microbial data are selected.
Fourthly, for the data analysis step, based on the cohort of cardiovascular diseases and neurological diseases, the association analysis of these candidate host genes and bacteria is conducted by using machine learning methods, and the construction and interpretation of relevant pathways are carried out in combination with previous studies. Mechanisms and pathways rise to the recognition of patterns for the construction of predictive models for early disease prevention and disease diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease group | – | –Collect data from patients with cardiovascular and neurological diseases, including blood and stool samples. Genome and transcriptome sequencing was performed on the collected blood samples. For fecal samples, metagenomic sequencing and metometabolic and proteomic sequencing were performed. |
| Healthy control group | – | –Collect data from healthy people, including blood and stool samples. Genome and transcriptome sequencing was performed on the collected blood samples. For fecal samples, metagenomic sequencing and metometabolic and proteomic sequencing were performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients from Shandong Province Qianfoshan Hospital.Based on electrocardiogram, blood test or B-ultrasonography and other examination methods, combined with clinical manifestations, patients judged by professional physicians as meeting the inclusion criteria of this experimental protocol will be included in the study cohort for study.
Key inclusion criteria (8 listed)
- Idiopathic ventricular tachycardia and frequent ventricular premature were recorded by routine 12-lead electrocardiogram or 24-hour holter electrocardiogram. It can meet the clinical diagnostic criteria of idiopathic speed and frequent ventricular premature.
- 18 years ≤ age ≤75 years.
- Moyamoya disease was confirmed by imaging examination.
- 18 years ≤ age ≤75 years.
- Imaging diagnosis confirmed no moyamoya disease.
Key exclusion criteria (31 listed)
- Patients with coronary heart disease, myocardial infarction, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other organic heart disease.
- Use of antibiotic drugs within 45 days.
- Routine 12-lead ECG or 24-hour holter ECG did not find idiopathic ventricular tachycardia and frequent ventricular premature.
- 18 years ≤ age ≤75 years.
- Patients with coronary heart disease, myocardial infarction, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other organic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stool sampling
Time frame: One month after the patient is clinically diagnosed with the above disease
① Sampling should be taken at the non-eating stage between 6am and 9am Before sampling, stool must be emptied into a clean and dry urinal or container containing filter paper. Note: Urine should not be mixed into the container. ② Use a small spoon in the sampler to collect feces. Note: In order to prevent contamination of the stool surface, gently peel the surface with a sampling spoon, and sample the inside of the stool, placing it in an average of three feces tubes. ③ After sampling, close the cover of the collector and mark the name and sampling time on the collector with a pen. Store at room temperature for 1 day, long-term storage at -80℃. Note: The sampler should not take antibiotics or other drugs for 45 days.
Blood collection
Time frame: One month after the patient is clinically diagnosed with the above disease
① Collect 5-10ml blood of the subject, centrifuge, collect serum and plasma, temporarily do not test, can be immediately frozen at low temperature, the lower the temperature is better, if not repeated freezing and thawing in the middle, can be stored for one month below -20℃, can be stored for three months below -80℃. ② Citrate anticoagulant and plasma collection: Sodium citrate acts as an anticoagulant by acting on calcium ion chelation in blood samples, recommended by the National Committee for Standardization of Clinical Laboratories (NCCLS) is 3.2% or 3.8%, and the anticoagulant to blood ratio is 1: 9, mainly used in the fibrinolytic system (prothrombin time, thrombin time, activated partial thrombin time, fibrinogen). When taking blood, attention should be paid to taking enough blood to ensure the accuracy of the test results, and the blood should be gently reversed and mixed 5-8 times immediately after taking blood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Background: PubMed 30712327Jin M, Qian Z, Yin J, Xu W, Zhou X. The role of intestinal microbiota in cardiovascular disease. J Cell Mol Med. 2019 Apr;23(4):2343-2350. doi: 10.1111/jcmm.14195. Epub 2019 Feb 3.
- Background: PubMed 30688023Jia Q, Xie Y, Lu C, Zhang A, Lu Y, Lv S, Zhang J. Endocrine organs of cardiovascular diseases: Gut microbiota. J Cell Mol Med. 2019 Apr;23(4):2314-2323. doi: 10.1111/jcmm.14164. Epub 2019 Jan 27.
- Background: PubMed 34729078Yan Q, Zhai W, Yang C, Li Z, Mao L, Zhao M, Wu X. The Relationship among Physical Activity, Intestinal Flora, and Cardiovascular Disease. Cardiovasc Ther. 2021 Oct 12;2021:3364418. doi: 10.1155/2021/3364418. eCollection 2021.
- Background: PubMed 35656118Zou Y, Song X, Liu N, Sun W, Liu B. Intestinal Flora: A Potential New Regulator of Cardiovascular Disease. Aging Dis. 2022 Jun 1;13(3):753-772. doi: 10.14336/AD.2021.1022. eCollection 2022 Jun.
- 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.
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 Nervous System Diseases and Cardiovascular and Cerebrovascular Diseases, run by Tao Xin 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 8 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 25 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Tao, Director of Neurosurgery (18888376796, drxintao@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool sampling (time frame: One month after the patient is clinically diagnosed with the above disease). 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?
On the ClinicalTrials.gov record for NCT06099496, which also lists 4 linked publications.
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 25 Oct 2023.