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

H

Huazhong University of Science and Technology

Status

Completed

Conditions

Unstable Angina
Coronary Heart Disease

Treatments

Other: take feces and blood samples from patients

Study type

Observational

Funder types

Other

Identifiers

NCT06562309
Trainedmono

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

high inflammatory risk
Description:
hsCRP ≥ 3mg/L
Treatment:
Other: take feces and blood samples from patients
low inflammatory risk
Description:
hsCRP \< 1mg/L
Treatment:
Other: take feces and blood samples from patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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