The Relationship Between Microbiota and Coronary Ectasia

The Evaluation of the Relationship Between Coronary Ectasia And Trimethylamine N Oxide

Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

2

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

      • Konya, Turkey, 42050
        • Necmettin Erbakan University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

In this study, patients with chronic stable angina who underwent coronary angiography were included after exclusion criteria.

Description

Inclusion Criteria:

  • over 18 years old
  • not having occlusive coronary artery disease
  • having coronary ectasia

Exclusion Criteria:

  • patients with chronic kidney disease,
  • revascularized coronary artery disease,
  • previously documented critical coronary stenosis,
  • acute or chronic inflammatory disease,
  • rheumatologic disease,
  • known active malignant disease,
  • heart failure,
  • moderate-to-severe valvular pathology
  • patients who were on any steroid or immunosuppressive therapy

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
Intervention / Treatment
coronary ectasia cohort
Patients with coronary ectasia detected on coronary angiography and without any exclusion criteria were included.
Taking blood for kit study (Elisa kit)
normal coronary cohort
Patients who underwent coronary angiography and did not have any of the exclusion criteria
Taking blood for kit study (Elisa kit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 1 month
Death from any cause within the last month
1 month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yakup Alsancak, Necmettin Erbakan University

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)

November 3, 2020

Primary Completion (Actual)

April 25, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 201518015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It was planned to share the trimethylamine N-oxide values obtained from the patients and the basic demographic data of the patients.

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.

Clinical Trials on Microbial Disease

Clinical Trials on Taking blood for kit study

Subscribe