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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Heart Disease (CHD)

• Study Type: Observational
• Enrollment (Estimated): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days to 6 months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ACS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2023YFC2413005 (Other Identifier: Ministry of Science and Technology of the People's Republic of China)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No