Is Our Microbiome a Predictor of Cardiac Risk

NCT ID: NCT02013284

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
2. Patients on chronic laxatives who cannot stop for at least 2 weeks prior to stool collection.
3. Patients on probiotics and cannot stop for 2 weeks prior to giving a stool sample (yogurt is ok).
4. 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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Amir Lerman

Amir Lerman, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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13-007084

Identifier Type: -

Identifier Source: org_study_id

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