Is Our Microbiome a Predictor of Cardiac Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is Our Microbiome a Predictor of Cardiac Risk?
Overview
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.
Primary outcome measures
- 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. [Time frame: 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. [Time frame: Two weeks after the angiogram]
Eligibility criteria
Inclusion criteria
Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.
Exclusion criteria
- Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
- Patients on chronic laxatives who cannot stop for at least 2 weeks prior to stool collection.
- Patients on probiotics and cannot stop for 2 weeks prior to giving a stool sample (yogurt is ok).
- 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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT02013284 · 13-007084