Acute Myocardial InfarctionNCT04955054
the Association of Intestinal Microbial Metabolites and Cardiac Function in Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Peking University Third Hospital at 1 site in China.
Trial summary
Recently, more and more studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases.Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- diagnose
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2020to 31 Dec 2025
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient, aged 18-85 years, had undergone coronary angiography and agreed to be enrolled and signed the informed consent. And they met the inclusion criteria and did not meet the exclusion criteria.
Who may be able to join
- The patient, aged 18-85 years, had undergone coronary angiography and agreed to be enrolled and signed the informed consent.
- AMI : according to ST segment elevation myocardial infarction diagnostic criteria.
- UAP:
- typical chest pain symptoms;
- negative in markers of myocardial injury;
- The stenosis of main coronary artery or its main branches is more than 50%
Show all 10Show fewer
- Control:
- atypical chest pain symptoms
- negative in markers of myocardial injury;
- The stenosis of main coronary artery and its main branches is less than 50%
Who cannot join
- Acute infection or application of antibiotics in the past 3 months;
- Chronic heart failure;
- History of inflammatory or absorptive bowel disease and bowel resection;
- Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 5 times of normal value);
- Renal insufficiency (serum creatinine > 220μml/L or creatinine clearance rate < 30 ml/min);
- Malignant tumor;
- Autoimmune diseases;
- Uninformed patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Guisong Wang, doctor, 13701070359, guisongwang@bjmu.edu.cn
Yunxiao Zhang, doctor, 18811333108, Zhang_doc@126.com
About this study
Recently, more and more studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases.Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.
Read the detailed description
Cardiovascular disease is the leading cause of death in China, and acute myocardial infarction (AMI) is the main cause of death of cardiovascular disease. In recent years, clinical epidemiological studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases such as diabetes, hyperlipidemia, hypertension, atherosclerosis, coronary heart disease, heart failure and so on. Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. It is suggested that intestinal flora and its metabolites participate in the pathophysiological process of cardiovascular disease through inflammation, oxidative stress and programmed death, and have the potential to be intervention targets. Basic and clinical studies have shown that TMAO is associated with the onset and poor prognosis of AMI by promoting the development of atherosclerosis and thrombosis, but there are few reports on the relationship between BAs or SCFA and AMI. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.
- Conditions
- Acute Myocardial Infarction
- Being tested
- diagnose
- Keywords
- bile acids, short chain fatty acid, cardiac function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnoseDiagnostic test
Patients from UAP and AMI meet the criteria of UAP or STEMI.
| Study group | Role | What they receive |
|---|---|---|
| control | patients without coronary artery disease | |
| UAP | patients without unstable angina pectoris Receives: Diagnostic Test: diagnose | |
| AMI | patients with acute myocardial infarction Receives: Diagnostic Test: diagnose |
What is being measured
The primary outcome is the main question the study is designed to answer.
the plasma levels of BAs and SCFA
the plasma levels of bile acids and short chain fatty acid in fast
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start11 Oct 2020
- Primary completion11 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955054
- Sponsor's protocol ID
- M2020362
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association of Intestinal Microbial Metabolites and Cardiac Function in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04955054
- Acronym / sponsor ID
- M2020362
- Conditions
- Acute Myocardial Infarction
- Keywords
- bile acids, short chain fatty acid, cardiac function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 11 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jul 2021 (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.
Recently, more and more studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases.Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.
Detailed description
Cardiovascular disease is the leading cause of death in China, and acute myocardial infarction (AMI) is the main cause of death of cardiovascular disease. In recent years, clinical epidemiological studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases such as diabetes, hyperlipidemia, hypertension, atherosclerosis, coronary heart disease, heart failure and so on. Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. It is suggested that intestinal flora and its metabolites participate in the pathophysiological process of cardiovascular disease through inflammation, oxidative stress and programmed death, and have the potential to be intervention targets. Basic and clinical studies have shown that TMAO is associated with the onset and poor prognosis of AMI by promoting the development of atherosclerosis and thrombosis, but there are few reports on the relationship between BAs or SCFA and AMI. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | –patients without coronary artery disease |
| UAP | – | Diagnostic Test: diagnosepatients without unstable angina pectoris |
| AMI | – | Diagnostic Test: diagnosepatients with acute myocardial infarction |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient, aged 18-85 years, had undergone coronary angiography and agreed to be enrolled and signed the informed consent. And they met the inclusion criteria and did not meet the exclusion criteria.
Key inclusion criteria (10 listed)
- The patient, aged 18-85 years, had undergone coronary angiography and agreed to be enrolled and signed the informed consent.
- AMI : according to ST segment elevation myocardial infarction diagnostic criteria.
- typical chest pain symptoms;
- negative in markers of myocardial injury;
- The stenosis of main coronary artery or its main branches is more than 50%
Key exclusion criteria (8 listed)
- Acute infection or application of antibiotics in the past 3 months;
- Chronic heart failure;
- History of inflammatory or absorptive bowel disease and bowel resection;
- Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 5 times of normal value);
- Renal insufficiency (serum creatinine > 220μml/L or creatinine clearance rate < 30 ml/min);
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 |
|---|---|---|
| diagnosePatients from UAP and AMI meet the criteria of UAP or STEMI. | Diagnostic test | AMI, UAP |
Primary outcome
the plasma levels of BAs and SCFA
Time frame: one week
the plasma levels of bile acids and short chain fatty acid in fast
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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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.
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 Acute Myocardial Infarction, run by Peking University Third Hospital 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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the plasma levels of BAs and SCFA (time frame: one week). 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 8 Jul 2021.