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Enrolling by Invitation

NCT Number: NCT02013284

Is Our Microbiome a Predictor of Cardiac Risk

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.

Enrolling by Invitation

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Blood samples will be obtained during the diagnostic angiogram.

Secondary outcomes

  1. Stool samples will be collected to compare the fecal microbiota of patients with mild, moderate and severe coronary artery disease.

    Time frame: Two weeks after the angiogram

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Is Our Microbiome a Predictor of Cardiac Risk?

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2013
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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