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

Non-ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331549
• Other study ID #: 2017020
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 5, 2017
• Start date: July 21, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2017
• Source: Beijing Anzhen Hospital
• Contact: Shao-Ping Nie, MD,PhD
• Phone: 86-10-84005256
• Email: spnie[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST-segment Elevation Myocardial Infarction

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beckman Coulter, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of non-ST-segment elevation myocardial infarction		After measuring the high-sensitivity troponin level at 1h or 3h
Secondary	Cardiovascular events or death		Follow-up for 6 months after diagnosis