Prospective Coronary Heart Disease Cohort

Sponsor

Shandong First Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05699629

Collaborator

Jinan Central Hospital (Other), Shandong Provincial Hospital Affiliated to Shandong First Medical University (Other), The Second Affiliated Hospital of Shandong First Medical University (Other), Qianfoshan Hospital (Other)

50,000

Enrollment

Location

Anticipated Duration (Months)

833.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Myocardial Infarction

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 21, 2022

Anticipated Primary Completion Date :

Jan 21, 2027

Anticipated Study Completion Date :

Jan 21, 2027

Outcome Measures

Primary Outcome Measures

major adverse cardiovascular events [2-year outcome and long-term outcome]
all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients 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:

Any subject who suffers from malignant tumors, infectious diseases, advanced liver disease, major disability and won't sign an inform consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong First Medical University	Jinan	Shandong	China	277500

Sponsors and Collaborators

Shandong First Medical University
Jinan Central Hospital
Shandong Provincial Hospital Affiliated to Shandong First Medical University
The Second Affiliated Hospital of Shandong First Medical University
Qianfoshan Hospital

Investigators

Study Chair: Tao Xu, Dr., Shandong First Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shandong First Medical University

ClinicalTrials.gov Identifier:

NCT05699629

Other Study ID Numbers:

2021-206-02

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Heart Diseases

Coronary Disease

Coronary Artery Disease

Myocardial Ischemia

Infarction

Study Results

No Results Posted as of Jan 26, 2023