NCT04955054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

bile acidsshort chain fatty acidcardiac function

Outcome Measures

Primary Outcomes (1)

  • the plasma levels of BAs and SCFA

    the plasma levels of bile acids and short chain fatty acid in fast

    one week

Study Arms (3)

control

patients without coronary artery disease

UAP

patients without unstable angina pectoris

Diagnostic Test: diagnose

AMI

patients with acute myocardial infarction

Diagnostic Test: diagnose

Interventions

diagnoseDIAGNOSTIC_TEST

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

AMIUAP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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%
  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Interventions

Diagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

October 11, 2020

Primary Completion

October 11, 2025

Study Completion

December 31, 2025

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations