Non-ST-segment Elevation Myocardial InfarctionNCT03331549
Study on High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population
An observational study of Non-ST-segment Elevation Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST-segment Elevation Myocardial Infarction
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients showing ST-segment elevation during ECG and pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@126.com
Shao-Ping Nie, MD, PhD
About this study
Official title: Study the High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial infarction | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of non-ST-segment elevation myocardial infarction
Measured: After measuring the high-sensitivity troponin level at 1h or 3h
Secondary outcomes (1)
Cardiovascular events or death
Measured: Follow-up for 6 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start21 Jul 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Coulter, Inc.
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331549
- Sponsor's protocol ID
- 2017020
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the High-sensitivity Troponin 0h/1h for Rapid Diagnosis of Non-ST-segment Elevation Myocardial Infarction in the Chinese Population
- ClinicalTrials.gov ID
- NCT03331549
- Acronym / sponsor ID
- 2017020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beckman Coulter, Inc.
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocardial infarction | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients showing ST-segment elevation during ECG and pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of non-ST-segment elevation myocardial infarction
Time frame: After measuring the high-sensitivity troponin level at 1h or 3h
1 secondary outcome
Cardiovascular events or death
Time frame: Follow-up for 6 months after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Related trials for Non-ST-segment Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ST-segment Elevation Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao-Ping Nie, MD,PhD (86-10-84005256, spnie@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of non-ST-segment elevation myocardial infarction (time frame: After measuring the high-sensitivity troponin level at 1h or 3h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.