Non-ST-elevation Myocardial Infarction (NSTEMI)HEADLINESNCT03734796
Hs-cTnI Diagnosis of NSTE-ACS Patients in China
An observational study of Non-ST-elevation Myocardial Infarction (NSTEMI), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I (hs-cTnI) in Chinese patients with suspected Non-ST-elevation Myocardial Infarction (NSTEMI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-ST-elevation Myocardial Infarction (NSTEMI)
- Type of treatment
- Injection or infusion
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2017to 31 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In primary phase of the present study, 400 patients with acute chest pain, who suspected NSTEMI, will be enrolled when visiting emergency department of Fuwai hospital. In subsequent study, multi center emergency department in China plan to recruit 2000 patients suspected NSTEMI. Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included. Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant.
Who may be able to join
- 18-75y;
- highly suspected NSTEMI;
- ECG results without ST-segment elevation;
- without new Left bundle branch block (LBBB) ;
Who cannot join
- STEMI;
- underwent major surgical operation or injury within four weeks;
- medium and several kidney dysfunction (Ccr<30ml/min);
- anemia(Hb<90g/L);
- acute myocarditis;
- chronic cardiac dysfunction (NYHA III-IV);
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- serious cardiac arrhythmias;
- Have had similar symptoms and treatment with thrombolysis before one month;
- history of intravenous drug;
- history of oncosis;
- pregnant;
- even recruited;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yan Liang
Beijing, Beijing Municipality, 100037
Yahui Lin, Ph.D., +8610-88398271, linyahui@263.net
About this study
Official title: The Study of High-sEnsitivity cArDiac Troponin I vaLues and Changes In diagNosis of suspEcted Acute Coronary Syndrome Patients in China
This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I (hs-cTnI) in Chinese patients with suspected Non-ST-elevation Myocardial Infarction (NSTEMI). The accuracy of 1-hour and 3-hours algorithm of NSTEMI using hs-cTnI assays will be evaluated in China emergency patients. This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or longer clinical diagnosis of MI in routine way.
Read the detailed description
Cardiac Troponin is recommended as a preferred cardiac biomarker in third universal definition of myocardial infraction. The validated high-sensitive cardiac troponin I is also considered competent 1-hour algorithm to rule out and/ rule in NSTEMI in 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. However, the diagnostic threshold of 1-hour and 3-hour need more solid evidence in Chinese population. This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I (hs-cTnI) in Chinese patients with suspected non-ST-elevation Myocardial Infarction (NSTEMI). The accuracy of 1-hour and 3-hours algorithm of NSTEMI using Architect hs-cTnI assays will be assessment in China emergency patients. This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or even longer clinical diagnosis of MI in routine way.
In primary phase of the present study, 400 patients with acute chest pain, who suspected NSTE-ACS, will be enrolled when visiting emergency department of Fuwai hospital. In subsequent study, multi center emergency department in China plan to recruit 2000 patients suspected NSTE-ACS. The inclusion and exclusion criteria had been described in the following eligibility part. All recruited patients undergo an initial clinical assessment including clinical history, physical examination, 12-lead ECG monitoring, routine blood measurements and echocardiogram. The blood samples of patients will be collected according to standard biobank protocol. Cardiac troponin I, CK-MB and myoglobin will be measured at presentation, 1-hour, 3-hours and 12-hours employing contemporary cTnI and high-sensitive cTnI, respectively.
The diagnosis of each enrolled patient will be made according to routine clinical approach and 1-hour and 3-hours clinical approach, respectively. The routine clinical diagnosis will be made by cardiologist panel according to third universal definition of myocardial infraction through reviewing all available medical records. The NSTEMI diagnosis depended on Architect hs-cTnI assessment will be made a senior cardiologist according to 1-hour and 3-hours clinical approach recommended by 2015 ESC guidelines for the management of NSTEMI. When there was disagreement about the diagnosis, cases were reviewed and adjudicated in conjunction with a third senior cardiologist.
Finally, statistical expert will evaluate the diagnostic performance of 1-hour and 3-hours clinical approach and diagnostic threshold of NSTEMI when the new hs-cTnI employed.
- Keywords
- High-sensitive cardiac troponin, Non-ST-elevation Myocardial Infarction (NSTEMI), Chinese, Acute chest pain
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
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 |
|---|---|---|
| suspected NSTEMI | Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included. Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Myocardial Infarction
Number of Participants with NSTEMI
Measured: 0 - 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start9 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST-elevation Myocardial Infarction (NSTEMI)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- 2,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yan Liang, MD, Study chair, Department of Emergency Medicine, State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Academy of Medical SciencesZhou Zhou, MD, PhD, Study chair, Center of Laboratory Medicine Beijing Key Laboratory for Molecular Diagnostics of Cardiovascular Disease State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Aca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734796
- Sponsor's protocol ID
- HEADLINES
- Acronym
- HEADLINES
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of High-sEnsitivity cArDiac Troponin I vaLues and Changes In diagNosis of suspEcted Acute Coronary Syndrome Patients in China
- ClinicalTrials.gov ID
- NCT03734796
- Acronym / sponsor ID
- HEADLINES / HEADLINES
- Keywords
- High-sensitive cardiac troponin, Non-ST-elevation Myocardial Infarction (NSTEMI), Chinese, Acute chest pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Nov 2018 (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.
This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I (hs-cTnI) in Chinese patients with suspected Non-ST-elevation Myocardial Infarction (NSTEMI). The accuracy of 1-hour and 3-hours algorithm of NSTEMI using hs-cTnI assays will be evaluated in China emergency patients. This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or longer clinical diagnosis of MI in routine way.
Detailed description
Cardiac Troponin is recommended as a preferred cardiac biomarker in third universal definition of myocardial infraction. The validated high-sensitive cardiac troponin I is also considered competent 1-hour algorithm to rule out and/ rule in NSTEMI in 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. However, the diagnostic threshold of 1-hour and 3-hour need more solid evidence in Chinese population. This study is to validate 1-hour and 3-hours diagnostic strategy using Architect high-sensitivity cardiac troponin I (hs-cTnI) in Chinese patients with suspected non-ST-elevation Myocardial Infarction (NSTEMI). The accuracy of 1-hour and 3-hours algorithm of NSTEMI using Architect hs-cTnI assays will be assessment in China emergency patients. This trail is going to determine the optimal diagnostic cut-off value of NSTEMI in Chinese population according to 24-hour or even longer clinical diagnosis of MI in routine way.
In primary phase of the present study, 400 patients with acute chest pain, who suspected NSTE-ACS, will be enrolled when visiting emergency department of Fuwai hospital. In subsequent study, multi center emergency department in China plan to recruit 2000 patients suspected NSTE-ACS. The inclusion and exclusion criteria had been described in the following eligibility part. All recruited patients undergo an initial clinical assessment including clinical history, physical examination, 12-lead ECG monitoring, routine blood measurements and echocardiogram. The blood samples of patients will be collected according to standard biobank protocol. Cardiac troponin I, CK-MB and myoglobin will be measured at presentation, 1-hour, 3-hours and 12-hours employing contemporary cTnI and high-sensitive cTnI, respectively.
The diagnosis of each enrolled patient will be made according to routine clinical approach and 1-hour and 3-hours clinical approach, respectively. The routine clinical diagnosis will be made by cardiologist panel according to third universal definition of myocardial infraction through reviewing all available medical records. The NSTEMI diagnosis depended on Architect hs-cTnI assessment will be made a senior cardiologist according to 1-hour and 3-hours clinical approach recommended by 2015 ESC guidelines for the management of NSTEMI. When there was disagreement about the diagnosis, cases were reviewed and adjudicated in conjunction with a third senior cardiologist.
Finally, statistical expert will evaluate the diagnostic performance of 1-hour and 3-hours clinical approach and diagnostic threshold of NSTEMI when the new hs-cTnI employed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected NSTEMI | – | –Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included. Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In primary phase of the present study, 400 patients with acute chest pain, who suspected NSTEMI, will be enrolled when visiting emergency department of Fuwai hospital. In subsequent study, multi center emergency department in China plan to recruit 2000 patients suspected NSTEMI. Patients aged 18-75 years old and highly suspected NSTEMI without Left bundle branch block (LBBB) will be included. Patients will be excluded if who is STEMI, underwent surgical operation within four weeks, medium and several kidney dysfunction (Ccr<30ml/min), anemia, acute myocarditis, chronic cardiac dysfunction (NYHA III-IV), serious cardiac arrhythmias, with history of intravenous drug, oncosis and recent thrombolysis treatment, or pregnant.
Key inclusion criteria (4 listed)
- 18-75y;
- highly suspected NSTEMI;
- ECG results without ST-segment elevation;
- without new Left bundle branch block (LBBB) ;
Key exclusion criteria (12 listed)
- STEMI;
- underwent major surgical operation or injury within four weeks;
- medium and several kidney dysfunction (Ccr<30ml/min);
- anemia(Hb<90g/L);
- acute myocarditis;
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
Acute Myocardial Infarction
Time frame: 0 - 72 hour
Number of Participants with NSTEMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Yan Liang, MD study chair
Department of Emergency Medicine, State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Academy of Medical Sciences
Zhou Zhou, MD, PhD study chair
Center of Laboratory Medicine Beijing Key Laboratory for Molecular Diagnostics of Cardiovascular Disease State Key Laboratory of Cardiovascular Disease National Center for Cardiovascular Diseases & Fuwai Hospital Peking Union Medical College & Chinese Aca
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-elevation Myocardial Infarction (NSTEMI), run by China National Center for Cardiovascular Diseases 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 4 inclusion and 12 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 8 Nov 2018. 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 Yan Liang, MD (+861088322803, fwliangyan2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Myocardial Infarction (time frame: 0 - 72 hour). 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 8 Nov 2018.