Coronary EctasiaNCT06384703
The Relationship Between Microbiota and Coronary Ectasia
An observational study of Coronary Ectasia and Microbial Disease, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Ectasia, Microbial Disease
- What is being tested?
- Taking blood for kit study
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2020to 18 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study, patients with chronic stable angina who underwent coronary angiography were included after exclusion criteria.
Who may be able to join
- over 18 years old
- not having occlusive coronary artery disease
- having coronary ectasia
Who cannot join
- 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,
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- heart failure,
- moderate-to-severe valvular pathology
- patients who were on any steroid or immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Ectasia, Microbial Disease
- Being tested
- Taking blood for kit study
- Keywords
- microbiota, endothelium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking blood for kit studyDiagnostic test
Taking blood for kit study (Elisa kit)
| Study group | Role | What they receive |
|---|---|---|
| coronary ectasia cohort | Patients with coronary ectasia detected on coronary angiography and without any exclusion criteria were included. Receives: Diagnostic Test: Taking blood for kit study | |
| normal coronary cohort | Patients who underwent coronary angiography and did not have any of the exclusion criteria Receives: Diagnostic Test: Taking blood for kit study |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Death from any cause within the last month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start3 Nov 2020
- Primary completion25 Apr 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary EctasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Sponsor
- Investigators
- Yakup Alsancak, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384703
- Sponsor's protocol ID
- 201518015
- Status last verified
- May 2021
- First submitted
- 16 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was planned to share the trimethylamine N-oxide values obtained from the patients and the basic demographic data of the patients.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Relationship Between Coronary Ectasia And Trimethylamine N Oxide
- ClinicalTrials.gov ID
- NCT06384703
- Acronym / sponsor ID
- 201518015
- Conditions
- Coronary Ectasia, Microbial Disease
- Keywords
- microbiota, endothelium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Collaborators
- Necmettin Erbakan University
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coronary ectasia cohort | – | Diagnostic Test: Taking blood for kit studyPatients with coronary ectasia detected on coronary angiography and without any exclusion criteria were included. |
| normal coronary cohort | – | Diagnostic Test: Taking blood for kit studyPatients who underwent coronary angiography and did not have any of the exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, patients with chronic stable angina who underwent coronary angiography were included after exclusion criteria.
Key inclusion criteria (3 listed)
- over 18 years old
- not having occlusive coronary artery disease
- having coronary ectasia
Key exclusion criteria (9 listed)
- patients with chronic kidney disease,
- revascularized coronary artery disease,
- previously documented critical coronary stenosis,
- acute or chronic inflammatory disease,
- rheumatologic disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking blood for kit studyTaking blood for kit study (Elisa kit) | Diagnostic test | coronary ectasia cohort, normal coronary cohort |
Primary outcome
death
Time frame: 1 month
Death from any cause within the last month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No. It was planned to share the trimethylamine N-oxide values obtained from the patients and the basic demographic data of the patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yakup Alsancak principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Ectasia and Microbial Disease, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.