The Relationship Between Microbiota and Coronary Ectasia

NCT06384703 | Completed

• 1 other identifier: 201518015
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

microbiota; endothelium

Outcome Measures

Primary Outcomes (1)

• death

  Death from any cause within the last month

  1 month

Study Arms (2)

coronary ectasia cohort

Patients with coronary ectasia detected on coronary angiography and without any exclusion criteria were included.

Diagnostic Test: Taking blood for kit study

normal coronary cohort

Patients who underwent coronary angiography and did not have any of the exclusion criteria

Diagnostic Test: Taking blood for kit study

Interventions

Taking blood for kit study DIAGNOSTIC_TEST

Taking blood for kit study (Elisa kit)

coronary ectasia cohort; normal coronary cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Beyhekim Training and Research Hospital: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Necmettin Erbakan University

Konya, 42050, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

A 3 ml blood sample was taken from the volunteer patients from the femoral artery and radial artery sheath entrance and kept at room temperature for 30 minutes. Then, it was centrifuged at 2500 r.p.m for 15 minutes to obtain a serum sample. The samples obtained within 6 months, which is the collection period of all patients, were stored in Eppendorf tubes at -80 degrees Celsius.

Study Officials

• Yakup Alsancak

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 25, 2024
• Study Start: November 3, 2020
• Primary Completion: April 25, 2021
• Study Completion: June 18, 2021
• Last Updated: April 25, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)