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NCT05965882 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05965882
Other study ID # BIOMS-IHD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date June 2024

Study information
Verified date January 2024
Source Beijing Institute of Heart, Lung and Blood Vessel Diseases
Contact Yuan Wang, PhD
Phone 13910161443
Email wangyuan980510@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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: - Current known inability to follow instructions or comply with follow-up procedures. - Eligible patients without informed consent form

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Beijing Anzhen Hospital Beijing Beijing

Sponsors (3)
Lead Sponsor Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases Beijing Luhe Hospital, The First Affiliated Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hospitalizations for acute heart failure (HF) Unplanned emergency visits or hospitalizations leading to HF deterioration were defined as hospitalizations for HF These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
Secondary Number of major adverse cardiovascular events (MACE) 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. These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
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