Is Our Microbiome a Predictor of Cardiac Risk

Is Our Microbiome a Predictor of Cardiac Risk?

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02013284

Enrollment

700

Registered

2013-12-17

Start date

2013-11-30

Completion date

2026-09-30

Last updated

2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results