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Fecal Microbiota and Monocyte Trained Immunity in CHD Patients With Different hsCRP

Fecal Microbiota and Monocyte Trained Immunity in Patients With Coronary Heart Disease and Different Level of High-sensitivity C-reactive Protein (hsCRP)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06562309
Enrollment
100
Registered
2024-08-20
Start date
2021-05-11
Completion date
2024-07-15
Last updated
2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Unstable Angina

Brief summary

This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Feces and blood samples were collected on admission were used promptly for ex vivo studies.

Detailed description

This single-center study enrolled patients aged 35-75 years who were diagnosed with unstable angina (UA), and had at least one of the three major coronary arteries with a ≥ 50% reduction in lumen diameter by angiographic visual estimation. Patients were all recruited at the Department of Cardiology, Union Hospital, Wuhan, Hubei Province, China. Exclusion criteria included acute myocardial infarction, prior myocardial infarction, malignancies, auto-immune or auto-inflammatory diseases, or ongoing infection. Feces and blood samples were collected on admission were used promptly for ex vivo studies. the aim of the study is to investigate whether the fecal microbiota and peripheral blood monocytes in patients with coronary heart disease at different levels of inflammation are associated with the level of inflammation.

Interventions

OTHERtake feces and blood samples from patients

this study does not involve any intervention

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years

Inclusion criteria

1. Age \>35 and \<75 years 2. Admitted for UA and had at least one of the three major coronary arteries with ≥50% reduction in lumen diameter by angiographic visual estimation 3. Informed consent obtained

Exclusion criteria

1. Prior myocardial infarction 2. Left ventricular ejection fraction ≤ 40% on echocardiography 3. Have a history of malignancies, auto-immune, auto-inflammatory disease or on immunomodulatory medication 4. Ongoing acute, chronic, or concurrent infectious disease 5. Surgery 3 months before sample collection 6. Immunization with a vaccine within 4 weeks before sample collection 7. Pregnancy, or breast feeding 8. History of primary or secondary immunodeficiency 9. Renal failure with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 10. Active liver disease with alanine aminotransferase (ALT \>80 U/L) or aspartate aminotransferase (AST \> 80 U/L) 11. History of chronic obstructive pulmonary disease (COPD) 12. Refuse to provide written consent 13. Any other circumstances in which the investigator judges that the patient is not suitable

Design outcomes

Primary

MeasureTime frameDescription
blood monocytes trained immunitywithin 3 days1.Blood monocytes were detected by flowcytometry to evaluate the monocyte subsets and CCR2 expression; 2. monocytes were enriched from blood cells and used for ex vivo lipopolysaccharide stimulation, mRNA sequencing and ATAC sequencing; 3.The metabolic bias of monocytes was detected by Seahorse technology and metabolics.

Secondary

MeasureTime frameDescription
fecal microbiome profilewithin 3 daysthe feccal microbiota was detected by 16s rRNA sequencing, and the analyses includes alpha and beta diversity, the differential microbiota between two groups, and the correlation between microbiota and clinical characteristics including age, BMI, blood lipids, and other available continous variables.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026