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NCT02013284 Clinical Trial

Is Our Microbiome a Predictor of Cardiac Risk

Coronary Artery Disease Clinical Trial

Official title:
Is Our Microbiome a Predictor of Cardiac Risk?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02013284
Other study ID # 13-007084
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2013
Est. completion date September 2024

Study information
Verified date October 2023
Source Mayo Clinic
Contact Anna Pick
Phone 507-255-0630
Email Pick.Anna@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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