Coronary Heart Disease (CHD)NCT06864676
Assessment of the Diagnostic Performance of the Detection System and Establishment of an Intelligent and Rapid Triage Model
An observational study of Coronary Heart Disease (CHD), run by China National Center for Cardiovascular Diseases.
Trial summary
The rapid triage of patients with acute chest pain remains an important issue in clinical practice. This study will establish a cohort of patients suspected of acute coronary syndrome (ACS) to construct a multi-marker dynamic combined intelligent triage model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD)
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese population aged 18 years and above, regardless of gender, with symptoms of chest tightness and chest pain, who need to be confirmed as acute coronary syndrome patients.
Who may be able to join
- Adults aged 18 years or above from China, regardless of gender;
- Presence of symptoms such as chest tightness and chest pain, with the need to determine whether they are patients with acute coronary syndrome;
- Ability to obtain informed consent.
Who cannot join
- - Patients with STEMI at the time of presentation;
- Patients with a clear diagnosis after tests such as troponin;
- Patients who have undergone major surgery or trauma within the past four weeks;
- Pregnant women or patients with tumors undergoing radiotherapy or chemotherapy;
- Patients who have previously participated in this study.
About this study
The rapid triage of patients with acute chest pain remains an important issue in clinical practice. This study will establish a cohort of patients suspected of acute coronary syndrome (ACS) to construct a multi-marker dynamic combined intelligent triage model. This model will triage the risk of NSTEMI in patients with chest pain at their first visit. It will also stratify the risk of patients with chest pain using major adverse cardiovascular events (MACE) within 30 days as the endpoint.
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- ACS
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction
in patients suspected of NSTEMI, using the baseline (0 hours) and any one of the 1-3 hour points for the ZR iStar (POCT) hs-cTnI two-point method, combined with the time from typical chest pain to the visit, to establish a triage machine learning model for NSTEMI through the training cohort, and to establish a multi-marker dynamic combination intelligent triage model for risk stratification of chest pain patients.
Measured: 30 days to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864676
- Sponsor's protocol ID
- 2023YFC2413005
- Other IDs
- 2023YFC2413005
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Diagnostic Performance of the Detection System and Establishment of an Intelligent and Rapid Triage Model
- ClinicalTrials.gov ID
- NCT06864676
- Acronym / sponsor ID
- 2023YFC2413005
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- ACS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- Mar 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Mar 2025 (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 rapid triage of patients with acute chest pain remains an important issue in clinical practice. This study will establish a cohort of patients suspected of acute coronary syndrome (ACS) to construct a multi-marker dynamic combined intelligent triage model. This model will triage the risk of NSTEMI in patients with chest pain at their first visit. It will also stratify the risk of patients with chest pain using major adverse cardiovascular events (MACE) within 30 days as the endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population aged 18 years and above, regardless of gender, with symptoms of chest tightness and chest pain, who need to be confirmed as acute coronary syndrome patients.
Key inclusion criteria (3 listed)
- Adults aged 18 years or above from China, regardless of gender;
- Presence of symptoms such as chest tightness and chest pain, with the need to determine whether they are patients with acute coronary syndrome;
- Ability to obtain informed consent.
Key exclusion criteria (5 listed)
- - Patients with STEMI at the time of presentation;
- Patients with a clear diagnosis after tests such as troponin;
- Patients who have undergone major surgery or trauma within the past four weeks;
- Pregnant women or patients with tumors undergoing radiotherapy or chemotherapy;
- Patients who have previously participated in this study.
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
Myocardial infarction
Time frame: 30 days to 6 months
in patients suspected of NSTEMI, using the baseline (0 hours) and any one of the 1-3 hour points for the ZR iStar (POCT) hs-cTnI two-point method, combined with the time from typical chest pain to the visit, to establish a triage machine learning model for NSTEMI through the training cohort, and to establish a multi-marker dynamic combination intelligent triage model for risk stratification of chest pain patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease (CHD), run by China National Center for Cardiovascular Diseases.
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 5 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarction (time frame: 30 days to 6 months). 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 7 Mar 2025.