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Is Our Microbiome a Predictor of Cardiac Risk

This study is currently recruiting participants.
Verified July 2017 by Amir Lerman, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02013284
First Posted: December 17, 2013
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
  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.

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?

Resource links provided by NLM:


Further study details as provided by Amir Lerman, 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. ]

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 ]

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: 200
Study Start Date: November 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013284


Contacts
Contact: Amir Lerman, MD 507-255-4152 lerman.amir@mayo.edu
Contact: Alysa Bleifus 507-255-7142 Bleifus.Alysha@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Diane Batzel, ACRC    507-538-7043    Batzel.Diane@mayo.edu   
Principal Investigator: Amir Lerman, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amir Lerman, MD Mayo Clinic
  More Information

Responsible Party: Amir Lerman, Amir Lerman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02013284     History of Changes
Other Study ID Numbers: 13-007084
First Submitted: December 11, 2013
First Posted: December 17, 2013
Last Update Posted: July 26, 2017
Last Verified: July 2017

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