Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06864676

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Coronary Heart Disease (CHD) Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Other outcomes

  1. High-sensitivity troponin

    Time frame: Concentrated detection once every three months

    Validation of instruments and test kits by detecting high-sensitivity troponin levels using different platforms.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.