Is Our Microbiome a Predictor of Cardiac Risk
1 other identifier
observational
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 11, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
October 16, 2025
October 1, 2025
12.8 years
December 11, 2013
October 14, 2025
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (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
Consenting participants who are undergoing coronary angiography.
You may qualify if:
- Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Biospecimen
Blood (50 cc) and stool samples will be collected on consenting participants. Participants will have the option of allowing us to store samples for future research
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Lerman, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Amir Lerman, MD
Study Record Dates
First Submitted
December 11, 2013
First Posted
December 17, 2013
Study Start
November 1, 2013
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 16, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share