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

NCT06562309 | Completed

• 1 other identifier: Trainedmono
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Unstable Angina

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• fecal microbiome profile

  within 3 days

Study Arms (2)

high inflammatory risk

hsCRP ≥ 3mg/L

Other: take feces and blood samples from patients

low inflammatory risk

hsCRP \< 1mg/L

Other: take feces and blood samples from patients

Interventions

take feces and blood samples from patients OTHER

this study does not involve any intervention

high inflammatory risk; low inflammatory risk

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

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

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Coronary Disease; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiang Cheng

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: May 11, 2021
• Primary Completion: April 30, 2024
• Study Completion: July 15, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CN (1)