Clinical trial NCT06562309: Fecal Microbiota and Monocyte Trained Immunity in CHD Patients With Different hsCRP
Official title: Fecal Microbiota and Monocyte Trained Immunity in Patients With Coronary Heart Disease and Different Level of High-sensitivity C-reactive Protein (hsCRP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Unstable Angina
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants This single-center study enrolled patients aged 35-75 years who were diagnosed with 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. UA diagnosis followed the 2014 AHA/ACC Guideline.18 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood monocytes trained immunity
timeFrame: within 3 days
Secondary outcomes:
measure: fecal microbiome profile
timeFrame: within 3 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiang Cheng
role: PRINCIPAL_INVESTIGATOR
References: