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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03331549
Enrollment
400
Registered
2017-11-06
Start date
2017-07-21
Completion date
2018-06-30
Last updated
2017-11-07

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

Conditions

Non-ST-segment Elevation Myocardial Infarction

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.

Interventions

None listed

Sponsors

Beckman Coulter, Inc.
CollaboratorINDUSTRY
Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Diagnosis of non-ST-segment elevation myocardial infarctionAfter measuring the high-sensitivity troponin level at 1h or 3h

Secondary

MeasureTime frame
Cardiovascular events or deathFollow-up for 6 months after diagnosis

Countries

China

Contacts

Primary ContactShao-Ping Nie, MD,PhD
spnie@126.com86-10-84005256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026