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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331549
Recruitment Status : Unknown
Verified November 2017 by Shao-Ping Nie, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Beckman Coulter, Inc.
Information provided by (Responsible Party):
Shao-Ping Nie, 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.

Condition or disease
Non-ST-segment Elevation Myocardial Infarction

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study the High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
Myocardial infarction
Control group



Primary Outcome Measures :
  1. Diagnosis of non-ST-segment elevation myocardial infarction [ Time Frame: After measuring the high-sensitivity troponin level at 1h or 3h ]

Secondary Outcome Measures :
  1. Cardiovascular events or death [ Time Frame: Follow-up for 6 months after diagnosis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331549


Contacts
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Contact: Shao-Ping Nie, MD,PhD 86-10-84005256 spnie@126.com

Locations
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China
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, China, 100029
Contact: Shao-Ping Nie, MD, PhD    86-10-84005256    spnie@126.com   
Principal Investigator: Shao-Ping Nie, MD, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
Beckman Coulter, Inc.
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Responsible Party: Shao-Ping Nie, Director, Emergency & Critical Care Center, Professor of Medicine, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03331549    
Other Study ID Numbers: 2017020
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases