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Is Our Microbiome a Predictor of Cardiac Risk

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT02013284
Collaborator
(none)
200
Enrollment
1
Location
106
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Is Our Microbiome a Predictor of Cardiac Risk?
    Study Start Date :
    Nov 1, 2013
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    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. [Blood samples will be obtained during the diagnostic angiogram.]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 utilizing Fed Ex overnight mail.

    5. Patients who have had previous Coronary Artery Bypass Grafting procedure

    6. Patients who have a colostomy

    7. Transplant Patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Amir Lerman, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amir Lerman, Amir Lerman, MD, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02013284
    Other Study ID Numbers:
    • 13-007084
    First Posted:
    Dec 17, 2013
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Feb 3, 2022