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

NCT ID: NCT03331549

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-21

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Non-ST-segment Elevation Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myocardial infarction

No interventions assigned to this group

Control group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Coulter, Inc.

INDUSTRY

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shao-Ping Nie

Director, Emergency & Critical Care Center, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shao-Ping Nie, MD,PhD

Role: CONTACT

Phone: 86-10-84005256

Email: [email protected]

Facility Contacts

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Shao-Ping Nie, MD, PhD

Role: primary

Other Identifiers

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2017020

Identifier Type: -

Identifier Source: org_study_id