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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955054
• Other study ID #: M2020362
• Status: Recruiting
• Start date: October 11, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 between gut and host. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: October 11, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• diagnose
Patients from UAP and AMI meet the criteria of UAP or STEMI.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the plasma levels of BAs and SCFA	the plasma levels of bile acids and short chain fatty acid in fast	one week