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

NCT06864676 | Not Yet Recruiting DMC

• 1 other identifier: 2023YFC2413005
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease (CHD)

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• High-sensitivity troponin

  Concentrated detection once every three months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Plasma or serum

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-02