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

NCT03009565 | Unknown

• 1 other identifier: 0622-16-RMC
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

coronary artery disease; human gut microbiota; microbiome

Outcome Measures

Primary Outcomes (2)

• humam gut microbiome analysis

  immediate

• TMAO levels

  immediate

Study Arms (2)

study patients

Study participants will be individuals aged 30-80 arriving to Rabin Medical Center with suspected CAD and able to provide informed consent. Participants will provide medical, lifestyle, and nutritional questionnaires. Blood pressure and heart-rate measurements will be taken during hospitalization as well as blood tests and fecal samples and/or rectal swabs. In order to evaluate and/or treat suspected atherosclerotic disease patients will undergo cardiac CT and/or cardiac catheterization in accordance with the standard of care and based upon the decision of the treating cardiologist. Diagnostics and treatment options will be based only on their medical condition and regardless of the aforementioned study protocol.

Other: coronary artery disease

control

The control group will be selected to represent an age, sex and cardiovascular risk factors -matched group without current CAD. Further exclusion criteria in the control group will be antibiotic consumption in the following 3 months, inflammatory bowel disease, or other significant chronic disease that may influence the microbiota (such as cancer, autoimmune disease, and chronic immunosuppressive treatment). The control group will undergo cardiac CT or coronary angiography according to clinical suspicion in order to rule-out CAD and irrespective of the study protocol.

Interventions

coronary artery disease OTHER

study patients

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be individuals aged 30-80 arriving to Rabin Medical Center with suspected CAD and able to provide informed consent. Participants will provide medical, lifestyle, and nutritional questionnaires. Blood pressure and heart-rate measurements will be taken during hospitalization as well as blood tests and fecal samples and/or rectal swabs. In order to evaluate and/or treat suspected atherosclerotic disease patients will undergo cardiac CT and/or cardiac catheterization in accordance with the standard of care and based upon the decision of the treating cardiologist. Diagnostics and treatment options will be based only on their medical condition and regardless of the aforementioned study protocol.

You may qualify if:

• aged 30-80
• arriving to Rabin Medical Center with suspected CAD
• able to provide informed consent

You may not qualify if:

• antibiotic consumption in the following 3 months
• inflammatory bowel disease
• other significant chronic disease that may influence the microbiota (such as cancer, autoimmune disease, and chronic immunosuppressive treatment)

Sponsors & Collaborators

• Rabin Medical Center: lead
• Weizmann Institute of Science: collaborator

Related Publications (15)

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Biospecimen

Retention: SAMPLES WITH DNA

blood rectal swab

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

JCAD protein, mouse

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Aviv A Shaul, Dr.

CONTACT

+972-54-2562671; aviv.shaul3@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: January 4, 2017

Record last verified: 2016-12