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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Unstable Angina
• Intervention / Treatment: Other: take feces and blood samples from patients

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
high inflammatory risk; hsCRP ≥ 3mg/L	Other: take feces and blood samples from patients; this study does not involve any intervention
low inflammatory risk; hsCRP < 1mg/L	Other: take feces and blood samples from patients; this study does not involve any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood monocytes trained immunity	1.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.	within 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fecal microbiome profile	the 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.	within 3 days

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Xiang Cheng, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina, Unstable
• Other Study ID Numbers: Trainedmono

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data and material are accessible in proper request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No