Coronary Heart DiseaseNCT06562309
Fecal Microbiota and Monocyte Trained Immunity in CHD Patients With Different hsCRP
An observational study of Coronary Heart Disease and Unstable Angina, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Unstable Angina
- What is being tested?
- take feces and blood samples from patients
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease, Unstable Angina
- Being tested
- take feces and blood samples from patients
- Medical subject headings
- Coronary Disease, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
take feces and blood samples from patientsOther
this study does not involve any intervention
| Study group | Role | What they receive |
|---|---|---|
| high inflammatory risk | hsCRP ≥ 3mg/L Receives: Other: take feces and blood samples from patients | |
| low inflammatory risk | hsCRP < 1mg/L Receives: Other: take feces and blood samples from patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 days
Secondary outcomes (1)
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.
Measured: within 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start11 May 2021
- Primary completion30 Apr 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiang Cheng, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562309
- Sponsor's protocol ID
- Trainedmono
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data and material are accessible in proper request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota and Monocyte Trained Immunity in Patients With Coronary Heart Disease and Different Level of High-sensitivity C-reactive Protein (hsCRP)
- ClinicalTrials.gov ID
- NCT06562309
- Acronym / sponsor ID
- Trainedmono
- Conditions
- Coronary Heart Disease, Unstable Angina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high inflammatory risk | – | Other: take feces and blood samples from patientshsCRP ≥ 3mg/L |
| low inflammatory risk | – | Other: take feces and blood samples from patientshsCRP < 1mg/L |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| take feces and blood samples from patientsthis study does not involve any intervention | Other | high inflammatory risk, low inflammatory risk |
Primary outcome
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.
1 secondary outcome
fecal microbiome profile
Time frame: within 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Undecided. The data and material are accessible in proper request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Cheng principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Unstable Angina, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood monocytes trained immunity (time frame: within 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.