Study on High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population

• Conditions: Non-ST-segment Elevation Myocardial Infarction

• Registration Number: NCT03331549
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

The purpose of the study is to establish a high-sensitivity troponin 0h/1h process for the diagnosis of patients suspected of NSTEMI for the Chinese population, obtain the inclusion and exclusion criteria for diagnosis of these patients and compare the new process with the existing diagnosing methods and processes, including the 3h and 6h processes more extensively used at present and the ECG combined with troponin diagnosis, so as to explore a confirmation model suitable for the Chinese population.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-21
• Status Verified: 2017-11
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-05
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-07
• Primary Completion: 2018-04-30
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients experiencing acute chest pain or angina pectoris symptom within 12 hours before visiting the hospital;
2. Or those experiencing acute chest pain or angina pectoris peak within 12 hours before visiting the hospital.

Exclusion Criteria

Patients showing ST-segment elevation during ECG and pregnant women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of non-ST-segment elevation myocardial infarction	After measuring the high-sensitivity troponin level at 1h or 3h

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events or death	Follow-up for 6 months after diagnosis

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China