Cardiovascular DiseasesNCT05965882
A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )
An observational study of Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
The registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Partients with ischemic heart disease accorrding to Inclusion and exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Current known inability to follow instructions or comply with follow-up procedures.
- Eligible patients without informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yuan Wang, PhD, 86-010-64456169, wangyuan980510@163.com
Jie Du, PhD
About this study
The registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Ischemic heart disease
- Medical subject headings
- Cardiovascular Diseases, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalizations for acute heart failure (HF)
Unplanned emergency visits or hospitalizations leading to HF deterioration were defined as hospitalizations for HF
Measured: These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
Secondary outcomes (1)
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.
Measured: These data is collected during follow-up visit at 3/6/12/24/36/48 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study startJun 2016
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Luhe Hospital, The First Affiliated Hospital of Shanxi Medical University
- Responsible party
- Sponsor
- Investigators
- Jie Du, phD, Study director, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965882
- Sponsor's protocol ID
- BIOMS-IHD
- Status last verified
- Jan 2024
- First submitted
- 20 Jul 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Biomarkers in Ischemic Heart Disease ( BIOMS-IHD )
- ClinicalTrials.gov ID
- NCT05965882
- Acronym / sponsor ID
- BIOMS-IHD
- Conditions
- Cardiovascular Diseases
- Keywords
- Ischemic heart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Beijing Luhe Hospital, The First Affiliated Hospital of Shanxi Medical University
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The registry study aims to discover biomarkers for accurate classification and risk assessment of ischemic heart disease.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Partients with ischemic heart disease accorrding to Inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Current known inability to follow instructions or comply with follow-up procedures.
- Eligible patients without informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Du, phD study director
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, PhD (13910161443, wangyuan980510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.