Association Analysis of Cardiovascular and Nervous System Diseases and Intestinal Microbiome Based on Multi-omics Big Data and Related Applications

NCT06099496 | Recruiting

• 1 other identifier: YXLL-KY-2023(037)
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

Research purpose

1. 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.) and nervous system diseases (such as carotid atherosclerosis, moyamoya disease, etc.).
2. 2.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.
3. 3.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.

Conditions

Nervous System Diseases; Cardiovascular and Cerebrovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  One month after the patient is clinically diagnosed with the above disease

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• years ≤ age ≤75 years.

You may not qualify if:

• 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.
• 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.
• Use of antibiotic drugs within 45 days.
• Patients with confirmed coronary heart disease or history of coronary heart disease, after interventional treatment, stent implantation, and regular CTA review.
• years ≤ age ≤75 years.
• CTA found no vascular restenosis.
• Use of antibiotic drugs within 45 days.
• Confirmed coronary heart disease or history of coronary heart disease, after interventional treatment, stent implantation, CTA examination did not find restenosis of blood vessels.
• years ≤ age ≤75 years.
• (1) Use of antibiotic drugs within 45 days.
• Moyamoya disease was confirmed by imaging examination.
• years ≤ age ≤75 years.

Sponsors & Collaborators

• Tao Xin: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 30712327 BACKGROUND

• Jia 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.

  PMID: 30688023 BACKGROUND

• Yan 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.

  PMID: 34729078 BACKGROUND

• Zou 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.

  PMID: 35656118 BACKGROUND

Biospecimen

DNA from the subjects' blood and stool

MeSH Terms

Conditions

Nervous System Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xin Tao, Director of Neurosurgery

CONTACT

18888376796; drxintao@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Neurosurgery

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: April 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: April 30, 2026
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CN (1)