NCT03331549

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

November 1, 2017

Last Update Submit

November 5, 2017

Conditions

Non-ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of non-ST-segment elevation myocardial infarction

    After measuring the high-sensitivity troponin level at 1h or 3h

Secondary Outcomes (1)

  • Cardiovascular events or death

    Follow-up for 6 months after diagnosis

Study Arms (2)

Myocardial infarction

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients visiting the Emergency Department of our hospital and have non-traumatic chest pain or other symptoms suggesting acute myocardial infarction will be selected.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

RECRUITING

Central Study Contacts

Shao-Ping Nie, MD,PhD

CONTACT

86-10-84005256spnie@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Emergency & Critical Care Center, Professor of Medicine

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

July 21, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

CN(1)