the Association of Intestinal Microbial Metabolites and Cardiac Function in Acute Myocardial Infarction

June 29, 2021 updated by: Peking University Third Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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:

  1. typical chest pain symptoms;
  2. negative in markers of myocardial injury;
  3. The stenosis of main coronary artery or its main branches is more than 50%

Control:

  1. atypical chest pain symptoms
  2. negative in markers of myocardial injury;
  3. The stenosis of main coronary artery and its main branches is less than 50%

Exclusion Criteria:

  1. Acute infection or application of antibiotics in the past 3 months;
  2. Chronic heart failure;
  3. History of inflammatory or absorptive bowel disease and bowel resection;
  4. Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 5 times of normal value);
  5. Renal insufficiency (serum creatinine > 220μml/L or creatinine clearance rate < 30 ml/min);
  6. Malignant tumor;
  7. Autoimmune diseases;
  8. Uninformed patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control
patients without coronary artery disease
UAP
patients without unstable angina pectoris
Diagnostic test: diagnose
Patients from UAP and AMI meet the criteria of UAP or STEMI.
AMI
patients with acute myocardial infarction
Diagnostic test: diagnose
Patients from UAP and AMI meet the criteria of UAP or STEMI.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the plasma levels of BAs and SCFA
Time Frame: one week
the plasma levels of bile acids and short chain fatty acid in fast
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2020362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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