Assessment of the Diagnostic Performance of the Detection System and Establishment of an Intelligent and Rapid Triage Model

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06864676

Enrollment

2000

Registered

2025-03-07

Start date

2025-03-31

Completion date

2027-12-31

Last updated

2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease (CHD)

Keywords

ACS

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* \- 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.

Design outcomes

Primary

Measure	Time frame	Description
Myocardial infarction	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.

Other

Measure	Time frame	Description
High-sensitivity troponin	Concentrated detection once every three months	Validation of instruments and test kits by detecting high-sensitivity troponin levels using different platforms.

Outcome results