Exploring the link between gut microbiome and cardiovascular and nervous system diseases

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

This study looks at how the bacteria in our gut might be linked to heart and brain diseases to see if we can predict risks and improve treatments.

Quick facts

• Study type: Observational
• Enrollment: 490 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan)
• Trial ID: NCT06099496 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between the intestinal microbiome and various cardiovascular and nervous system diseases using multi-omics data and advanced data mining techniques. It aims to identify the pathogenesis of these diseases and develop a risk prediction model based on dietary and clinical information. Additionally, the study seeks to construct machine learning models to aid in the prevention and treatment of these conditions by analyzing key genes and microorganisms involved.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 75 with idiopathic ventricular tachycardia or frequent ventricular premature beats.

Not a fit: Patients with existing organic heart diseases or those who have used antibiotics within the last 45 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to innovative approaches for preventing and treating cardiovascular and nervous system diseases through microbiome modulation.

How similar studies have performed: While the role of gut microbiota in health is gaining attention, this specific approach combining multi-omics data and machine learning is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion criteria of idiopathic ventricular tachycardia:

1. 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.
2. 18 years ≤ age ≤75 years.

Exclusion criteria for idiopathic ventricular tachycardia:

1. Patients with coronary heart disease, myocardial infarction, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other organic heart disease.
2. Use of antibiotic drugs within 45 days.

Case control inclusion criteria for idiopathic ventricular tachycardia:

1. Routine 12-lead ECG or 24-hour holter ECG did not find idiopathic ventricular tachycardia and frequent ventricular premature.
2. 18 years ≤ age ≤75 years.

Case-control exclusion criteria for idiopathic ventricular tachycardia:

1. Patients with coronary heart disease, myocardial infarction, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease, heart failure and other organic heart disease.
2. Use of antibiotic drugs within 45 days.

Inclusion criteria of postoperative coronary artery stenosis injury cases:

1. Patients with confirmed coronary heart disease or history of coronary heart disease, after interventional treatment, stent implantation, and regular CTA review.
2. 18 years ≤ age ≤75 years.

Exclusion criteria for postoperative coronary artery stenosis injury cases:

1. CTA found no vascular restenosis.
2. Use of antibiotic drugs within 45 days.

Inclusion criteria for case control of postoperative vascular stenosis injury in coronary heart disease:

1. Confirmed coronary heart disease or history of coronary heart disease, after interventional treatment, stent implantation, CTA examination did not find restenosis of blood vessels.
2. 18 years ≤ age ≤75 years.

Case-control exclusion criteria for postoperative vascular stenosis injury of coronary heart disease:

(1) Use of antibiotic drugs within 45 days.

Inclusion criteria of moyamoya disease cases:

1. Moyamoya disease was confirmed by imaging examination.
2. 18 years ≤ age ≤75 years.

Exclusion criteria for moyamoya disease cases:

1. Previous history of vascular surgery or trauma
2. Use of antibiotic drugs within 45 days.

Inclusion criteria of moyamoya disease control cases:

1. Imaging diagnosis confirmed no moyamoya disease.
2. 18 years ≤ age ≤75 years.

Exclusion criteria for control cases of moyamoya disease:

1. Previous history of vascular surgery or trauma.
2. Use of antibiotic drugs within 45 days.

Inclusion criteria of carotid atherosclerosis cases:

1. Carotid atherosclerosis was confirmed by ultrasound, CTA and other imaging examinations.
2. 18 years ≤ age ≤75 years.

Exclusion criteria for carotid atherosclerosis cases:

1. Previous history of carotid vascular surgery or trauma.
2. Use of antibiotic drugs within 45 days.

Inclusion criteria for carotid atherosclerosis case control:

1. Carotid ultrasound showed no atherosclerosis.
2. 18 years ≤ age ≤75 years.

Carotid atherosclerosis case-control exclusion criteria:

1. Previous history of carotid vascular surgery or trauma.
2. Use of antibiotic drugs within 45 days.

Where this trial is running

Jinan

• The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital — Jinan, China (Recruiting)

Study contacts

• Study coordinator: Xin Tao, Director of Neurosurgery

Conditions Nervous System Diseases; Cardiovascular and Cerebrovascular Diseases