Is Our Microbiome a Predictor of Cardiac Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02013284
First received: December 11, 2013
Last updated: July 27, 2016
Last verified: April 2016

December 11, 2013
July 27, 2016
November 2013
October 2016   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02013284 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
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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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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
Non-Probability Sample
Consenting participants who are undergoing coronary angiography.
Coronary Artery Disease
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2017
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Amir Lerman, MD 507-255-4152 lerman.amir@mayo.edu
Contact: Diane Batzel, ACRC 507-538-7043 batzel.diane@mayo.edu
United States
 
NCT02013284
13-007084
No
Not Provided
Not Provided
Amir Lerman, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Amir Lerman, MD Mayo Clinic
Mayo Clinic
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP