ASSOCIATION OF GUT MICROBIOTA WITH DYSLIPIDEMIA AND CHRONIC CORONARY SYNDROME PATIENTS UNDERGOING CORONARY ANGIOGRAPHY

• Conditions: The first group: Healthy volunteersThe second group: Patients with cardiovascular risk factors, dyslipidemiaThe third group: Patients with chronic coronary syndrome undergoing coronary angiography; 1. Healthy volunteers; 2. Patients with cardiovascular risk factors, dyslipidemia; 3. Patients with chronic coronary syndrome undergoing coronary angiography

• Registration Number: TCTR20230428002
• Lead Sponsor: Faculty of Medicine, Srinakharinwirot University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Study Completion: 2023-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

The first group: Healthy volunteers
1. Volunteers must be 35-70 years old
2. Volunteers must not have any of the following risk factors for cardiovascular disease
- Dyslipidemia
- Type 2 diabetes mellitus
- Hypertension
- Obesity
- Metabolic syndrome.
3. Volunteers must not have acute coronary syndrome or chronic coronary syndrome
4. Volunteers are willing to participate in the research by signing the consent forms

The second group: Patients with cardiovascular risk factors, dyslipidemia
1. Volunteers must be 35-70 years old
2. Volunteers must have a risk factor for cardiovascular disease, dyslipidemia
3. Volunteers must not have any of the following risk factors for cardiovascular disease
- Type 2 diabetes mellitus
- Hypertension
- Obesity
- Metabolic syndrome.
4. Volunteers are willing to participate in the research by signing the consent forms.

The third group: Patients with chronic coronary syndrome undergoing coronary angiography
1. Volunteers must be 35-70 years old
2. Volunteers with chronic coronary syndrome undergoing coronary angiography
Chronic coronary syndrome patients refer to the patients with angina pectoris due to demand-supply mismatch which cause myocardial ischemia. Coronary anatomy is greater than 70% stenosis in coronary arteries that are larger than 2.5 mm in one view of coronary angiogram, greater than 50% stenosis in coronary arteries in more than two views of coronary angiogram and greater than 50% stenosis in the left main coronary artery.
3. Volunteers are willing to participate in the research by signing the consent forms

Exclusion Criteria

1. Volunteers with underlying disease including chronic kidney disease (eGFR < 60 ml/min/1.73 m2 for more than 3 months), liver disease (AST/ALT > 5 times normal or jaundice), cancer, intestinal diseases such as inflammatory bowel disease, thyroid dysfunction, immunodeficiency such as human immunodeficiency virus (HIV)
2. Volunteers who take antibiotics, immunosuppressants, probiotics supplement, synbiotics, herbal supplements, antacids or laxatives within 4 weeks before participating in the study
3. Volunteers who have history of gastrointestinal disease and other infections within 4 weeks
4. Volunteers who smoke
5. Volunteers with alcoholism
6. Volunteers who are pregnant or lactating
7. Volunteers who have Covid-19 infection within 4 weeks
8. Volunteers who refuse to participate in the research

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition and related parameters At 12 months after end of the intervention Illumina MiSeq, analyzed with UCLUST from QIIME 2 2019.10 software in conjunction with the Zymo database

Secondary Outcome Measures

Name	Time	Method
Gut microbiota diversity At 12 months after end of the intervention Illumina MiSeq, analyzed with UCLUST from QIIME 2 2019.10 software in conjunction with the Zymo database,Influence of dietary habits on gut microbiota profiles At 12 months after end of the intervention Illumina MiSeq, analyzed with UCLUST from QIIME 2 2019.10 software in conjunction with the Zymo database