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

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: Recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: diagnose

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: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Guisong Wang, doctor; Phone Number: 13701070359; Email: guisongwang@bjmu.edu.cn
      • Contact: Yunxiao Zhang, doctor; Phone Number: 18811333108; Email: Zhang_doc@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
the plasma levels of BAs and SCFA	the plasma levels of bile acids and short chain fatty acid in fast	one week

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2020
• Primary Completion (Anticipated): October 11, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: bile acids; cardiac function; short chain fatty acid
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID 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