Is Our Microbiome a Predictor of Cardiac Risk | NCT02013284

Studies
Is Our Microbiome a Predictor of Cardiac Risk

NCT02013284

Sponsor

Mayo Clinic

Status

Enrolling by invitation

Last Update Posted

Oct 16, 2025Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

United States

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

Oct 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Dec 11, 2013

First Submission Date that Met QC Criteria

Dec 11, 2013

First Posted Date

Dec 17, 2013Estimated

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

Oct 14, 2025

Last Update Posted Date

Oct 16, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine a relationship between a person's flora/bacteria in their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut.

Detailed Description

Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut. This research is being done because Investigators believe that there is a connection between the way food is digested by a person's gut bacteria and the development of atherosclerosis (hardening of the arteries) and cardiovascular disease. The ultimate goal of this research is to eventually determine if changes to the gut bacteria can prevent cardiovascular disease or disease progression.

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

700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
50 cc blood obtained during angiogram and used for Endothelial Progenitor Cells analysis using antibodies for inflammatory markers. Plasma collection will be done for antibody analysis. Buffy coats will be frozen and stored for future genetic analysis.		Blood samples will be obtained during the diagnostic angiogram.

Secondary Outcomes

Measure	Description	Time Frame
Stool samples will be collected to compare the fecal microbiota of patients with mild, moderate and severe coronary artery disease.		Two weeks after the angiogram

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.

Exclusion Criteria:

Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
Patients on chronic laxatives who cannot stop for at least 2 weeks prior to stool collection.
Patients on probiotics and cannot stop for 2 weeks prior to giving a stool sample (yogurt is ok).
Patients who are unable to provide a stool sample to Mayo Clinic within 24 hours of collection utilizing Fed Ex overnight mail (i.e. people overseas who are unable to provide a sample before leaving the USA.)

Accepts Healthy Volunteers

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

Consenting participants who are undergoing coronary angiography.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Lerman, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

Not provided