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Does the Human Gut Microbiome Serve as a Novel Personalized Therapeutic Target for Coronary Atherosclerosis?

NCT03009565 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2017-01-04

No results posted yet for this study

Summary

Background: The human gastrointestinal system is populated with a variety of symbiotic microorganisms, namely microbiota. The microbiome is the total genetic data of the microbiota. The human gut microbiota interacts extensively with the host through metabolic exchange; thereby contribute to a variety of metabolic and immunologic mechanisms in the human body. Coronary artery disease (CAD) is major cause of morbidity and mortality worldwide and is a major field of interest in microbiota research. There have been several findings that connect the gut microbiota to CAD pathophysiology, but these data relates solely to the interaction between human gut microbiome and cardiovascular risk factors. As far as known , data regarding patients who already developed CAD is lacking.

Aims: To investigate gut microbiota of patients with CAD, thereby allowing the adjustment of personalized treatment by changing the pro-atherosclerotic environment in the gut.

Methods: Study participants will include patients arriving to Rabin Medical Center with suspected CAD. Patients will provide medical, lifestyle, and nutritional questionnaires. Vital signs measurements will be taken as well as fecal samples and/or rectal swabs. Blood samples will be drawn to measure blood chemistry including lipid profile and trimethylamine-N-oxide (TMAO) levels. Patients will undergo cardiac CT and/or cardiac catheterization in accordance with the decision of the cardiologist to evaluate and/or treat CAD. Genomic DNA will be extracted from stool samples for Microbiome analysis.

Innovation: The hypothesis is that there is a unique microbiota pattern in patients with coronary atherosclerosis, which may contribute to the pathogenesis and/or expression of CAD. Knowing the unique microbiota in patients with coronary disease, would render it as novel target for treatment, either primary or secondary prevention.

Collaboration: Between Cardiology department at Rabin Medical Center and the lab of Prof. Eran Segal located at the Weizmann Institute of Science. The collaboration between these two groups will combine the clinical expertise of treating cardiac patients with novel scientific technology and concept.

Conditions

  • Coronary (Artery) Disease

Interventions

OTHER

coronary artery disease

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Rabin Medical Center

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009565 on ClinicalTrials.gov