Is Our Microbiome a Predictor of Cardiac Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02013284
First received: December 11, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Our Microbiome a Predictor of Cardiac Risk?

Further study details as provided by Mayo Clinic:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consenting participants who are undergoing coronary angiography.

Criteria

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 who are unable to provide a stool sample to Mayo Clinic within 24 hours of collection via Fed Ex overnight mail.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013284

Contacts
Contact: Amir Lerman, MD 507-255-4152 lerman.amir@mayo.edu
Contact: Rebecca E. Nelson, CCRC 507-255-8388 nelson.rebecca@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rebecca E. Nelson, CCRC    507-255-8388    nelson.rebecca@mayo.edu   
Principal Investigator: Amir Lerman, MD         
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Amir Lerman, Amir Lerman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02013284     History of Changes
Other Study ID Numbers: 13-007084
Study First Received: December 11, 2013
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014