Fecal Microbiota and Monocyte Trained Immunity in CHD Pat... | NCT06562309

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

NCT06562309

Sponsor

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

Status

Completed

Last Update Posted

Aug 20, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Coronary Heart Disease
Unstable Angina

Interventions

take feces and blood samples from patients

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2021Actual

Primary Completion Date

Apr 30, 2024Actual

Completion Date

Jul 15, 2024Actual

First Submitted Date

Aug 14, 2024

First Submission Date that Met QC Criteria

Aug 15, 2024

First Posted Date

Aug 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2024

Last Update Posted Date

Aug 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
take feces and blood samples from patients	Other	this study does not involve any intervention	high inflammatory risk low inflammatory risk

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Xiang Cheng	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The data and material are accessible in proper request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003327	Coronary Disease
D000789	Angina, Unstable

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases