Is Our Microbiome a Predictor of Cardiac Risk

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT02013284
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-11
• Study First Posted: 2013-12-17
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States