The Relationship Between Microbiota and Coronary Ectasia | NCT06384703

Studies
The Relationship Between Microbiota and Coronary Ectasia

NCT06384703

Sponsor

Konya Beyhekim Training and Research Hospital

Status

Completed

Last Update Posted

Apr 25, 2024Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Coronary Ectasia
Microbial Disease

Interventions

Taking blood for kit study

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2020Actual

Primary Completion Date

Apr 25, 2021Actual

Completion Date

Jun 18, 2021Actual

First Submitted Date

Apr 16, 2024

First Submission Date that Met QC Criteria

Apr 24, 2024

First Posted Date

Apr 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2024

Last Update Posted Date

Apr 25, 2024Actual

Name	Class
Necmettin Erbakan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Taking blood for kit study	Diagnostic Test	Taking blood for kit study (Elisa kit)	coronary ectasia cohort normal coronary cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yakup Alsancak	Necmettin Erbakan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necmettin Erbakan University		Konya		42050	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

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.