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NCT05699629 Clinical Trial

Prospective Coronary Heart Disease Cohort

Myocardial Infarction Clinical Trial

Official title:
A Prospective Longitudinal Multi-Omics Cohort of Patients With Coronary Heart Disease Undergoing Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05699629
Other study ID # 2021-206-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2022
Est. completion date January 21, 2027

Study information
Verified date February 2023
Source Shandong First Medical University
Contact Rong Huang, Dr.
Phone 18854125717
Email huangrong9277@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the biomarkers for the prognosis of coronary heart disease, patients with coronary heart disease will be recruited and followed up for at least 2 years.

Description:

Patients with cardiovascular disease undergoing coronary angiography will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as socio-demographic, diet, lifestyle, psychological status and medical history. The biomarkers for the incidence of coronary heart disease and the factors contributing to the poor prognosis of coronary heart disease will be investigated based on multi-omics analysis.

Recruitment information / eligibility
Status Recruiting
Enrollment 50000
Est. completion date January 21, 2027
Est. primary completion date January 21, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed as coronary heart disease or with unexplained chest pain needed to undergo coronary angiography. - Healthy subjects undergoing routine physical examination in the physical examination department and willing to sign informed consent will be recruited as control subjects. Exclusion Criteria: - With malignant tumors, infectious diseases and advanced liver diseases. - Won't sign an inform consent.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Shandong First Medical University Jinan Shandong

Sponsors (5)
Lead Sponsor Collaborator
Shandong First Medical University Jinan Central Hospital, Qianfoshan Hospital, Shandong Provincial Hospital Affiliated to Shandong First Medical University, The Second Affiliated Hospital of Shandong First Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary major adverse cardiovascular events all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization 2-year outcome and long-term outcome
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