Multi-omics Study of Young Adults Coronary Syndrome Patients

NCT04864457 | Unknown

• 1 other identifier: Young-COSMOS.001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

With the rapid development of China's economy, changes in diet structure, lifestyle and excessive mental pressure have led to a younger trend in the incidence of ACUTE coronary syndrome, and the mortality rate has been on the rise, especially in Shenzhen, the country with the youngest average age.Coronary heart disease among young people not only reduces the quality of life and loses the ability to work, but also prematurely consumes medical resources and increases social costs, bringing heavy burdens to families and society.Therefore, it is of great significance to conduct researches on the transcription, metabolism and microbiome of young patients with ACUTE coronary syndrome and obtain the multi-group characteristics of these patients for early warning, guiding the improvement of life style, regulating treatment, improving treatment rate, and reducing family and social burden.

Conditions

Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• Frequencies of alteration of RNA expression

  The alteration of RNA expression, including mRNA, circRNA, and lncRNA, will be compared among young patients with normal coronary artery, chronic coronary syndrome and acute coronary syndrome by transcriptome sequencing.

  During sample collection (1 year)

• Frequencies of alteration of gut microbiome

  The alteration of Gut Microbiome will be compared young patients with normal coronary artery, chronic coronary syndrome and acute coronary syndrome by metagenomic tests on fecal DNA with the Illumina NovaseQ6000 sequencing platform.

  During sample collection (1 year)

Secondary Outcomes (3)

• Alteration of inflammatory factors

  During sample collection (1 year)

• Alteration of dietary habit

  During sample collection (1 year)

• Frequencies of alteration of metabolites

  During sample collection (1 year)

Study Arms (3)

Normal

Patients without coronary atherosclerotic burden

Chronic coronary syndrome (CCS)

CCS covers the different stages of development of coronary heart disease in addition to the clinical manifestations dominated by acute coronary thrombosis, including asymptomatic myocardial ischemia, vasospasm, and microcirculatory lesions. The six most common types of CCS include:Suspected coronary heart disease and "stable" angina symptoms, whether or not patients with dyspnea; Patients with newly emerged heart failure or left ventricular dysfunction suspected of CAD; Patients with no symptoms or stable symptoms within 1 year after ACS, or patients with recent revascularisation; Patients with or without symptoms more than 1 year after initial diagnosis or revascularization; Patients with angina pectoris, suspected vasospasm or microcirculatory diseases; Asymptomatic patients with coronary heart disease are found during screening.

Acute coronary syndrome (ACS)

ACS is a group of clinical syndromes commonly characterized by acute myocardial ischemia, including unstable angina pectoris (UA); Acute non-ST-segment elevation myocardial infarction (NSTEMI); Acute ST-segment elevation myocardial infarction (STEMI).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 to 45 years with normal coronary artery, chronic coronary syndrome or acute coronary syndrome

You may qualify if:

• Clinical diagnosis of normal coronary artery, chronic coronary syndrome or acute coronary syndrome by coronary angiography and clinical symptoms
• years old

You may not qualify if:

• Patients with gastrointestinal diseases, recent 3 months of diarrhea, malignant tumors, autoimmune diseases and infectious diseases
• Patients with renal insufficiency (severe kidney disease creatinine \> 267 mol/L)
• Patients with gastrointestinal surgery history within 1 year
• Patients with antibiotic use for more than 3 days within 3 months

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cell, plasma, faeces

MeSH Terms

Conditions

Angina, Unstable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaohong Dong, MD

  Shenzhen People's Hospital

  STUDY CHAIR

Central Study Contacts

Xin Sun, MD

CONTACT

+86-755-22943205; sunxinflying@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: April 28, 2021
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CN (1)