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Completed

NCT Number: NCT06562309

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

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

take feces and blood samples from patients

Other

this study does not involve any intervention

Primary outcomes

  1. blood monocytes trained immunity

    Time frame: within 3 days

    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.

Secondary outcomes

  1. fecal microbiome profile

    Time frame: within 3 days

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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