- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384703
The Relationship Between Microbiota and Coronary Ectasia
April 24, 2024 updated by: Konya Beyhekim Training and Research Hospital
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
Conditions
Intervention / Treatment
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.
Collaborators
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
Keywords
Additional Relevant MeSH Terms
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.
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