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

January 25, 2024 updated by: Beijing Institute of Heart, Lung and Blood Vessel Diseases
The registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
        • Principal Investigator:
          • Jie Du, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Partients with ischemic heart disease accorrding to Inclusion and exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hospitalizations for acute heart failure (HF)
Time Frame: 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
These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of major adverse cardiovascular events (MACE)
Time Frame: 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.
These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Collaborators

The First Affiliated Hospital of Shanxi Medical University
Beijing Luhe Hospital

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOMS-IHD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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