A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT05965882

Collaborator

Beijing Luhe Hospital (Other), The First Affiliated Hospital of Shanxi Medical University (Other)

5,000

Enrollment

Location

Anticipated Duration (Months)

52.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases

Detailed Description

The purpose of this study is to discover biomarkers for early identification, diagnosis, molecular classification, and intervention based on the mechanism of ischemic heart disease（IHD）. Using mass spectrometry-based metabolomics and multimodal imaging technology, the study aims to further construct a new system for early risk stratification of IHD based on abnormal metabolites.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )

Actual Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Outcome Measures

Primary Outcome Measures

Number of hospitalizations for acute heart failure (HF) [These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge]
Unplanned emergency visits or hospitalizations leading to HF deterioration were defined as hospitalizations for HF

Secondary Outcome Measures

Major adverse cardiovascular events (MACE) [These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge]
Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure hospitalization, recurrent myocardial infarction, stroke or ischemia-driven revascularization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria :

Aged 18 years or older.
Previous ischemic symptoms/signs or electrocardiographic ischemic changes and.
70% stenosis of at least one epicardial coronary artery on angiography or a history of myocardial infarction or coronary revascularization.

Exclusion Criteria:

Patients with acute myocardial infarction were excluded from the study.
Current known inability to follow instructions or comply with follow-up procedures.
Eligible patients without informed consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

Beijing Institute of Heart, Lung and Blood Vessel Diseases
Beijing Luhe Hospital
The First Affiliated Hospital of Shanxi Medical University

Investigators

Study Director: Jie Du, phD, The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases