Is Our Microbiome a Predictor of Cardiac Risk

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Anna Pick; Phone Number: 507-255-0630; Email: pick.anna@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Anna Pick; Phone Number: 507-255-0630; Email: pick.anna@mayo.edu
      • Principal Investigator: Amir Lerman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consenting participants who are undergoing coronary angiography.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amir Lerman, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimated): December 17, 2013

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 13-007084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No