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

NCT ID: NCT04955054

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-11
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

control

patients without coronary artery disease

No interventions assigned to this group

UAP

patients without unstable angina pectoris

diagnose

Intervention Type: DIAGNOSTIC_TEST

Patients from UAP and AMI meet the criteria of UAP or STEMI.

AMI

patients with acute myocardial infarction

diagnose

Intervention Type: DIAGNOSTIC_TEST

Patients from UAP and AMI meet the criteria of UAP or STEMI.

Interventions

diagnose

Patients from UAP and AMI meet the criteria of UAP or STEMI.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Guisong Wang, doctor

Role: primary

guisongwang@bjmu.edu.cn

13701070359

Yunxiao Zhang, doctor

Role: backup

Zhang_doc@126.com

18811333108

Other Identifiers

M2020362

Identifier Type: -

Identifier Source: org_study_id