Non-ST Elevated Myocardial InfarctionNCT04710446
Clinical Characteristics, Treatments, and Outcomes of MI Patients Presenting With Normal ECG
An observational study of Non-ST Elevated Myocardial Infarction and Electrocardiography, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
the investigators aimed to analyzed data for hospitalized MI patients with normal ECG. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Non-ST Elevated Myocardial Infarction, Electrocardiography
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Jan 2023
- How long will I take part?
- 1 Year
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSTEMI Patients
Inclusion Criteria:all patients hospitalized with a principal diagnosis of non-ST-segment elevation infarction (NSTEMI) according to the current ACC/AHA guidelines.
exclusion criteria: end-stage organic disease, thrombotic hematological disorders, and poor echogenicity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan province people's hospital
Zhengzhou, Henan
yansheng Huang
About this study
the investigators aimed to analyzed data for hospitalized MI patients with normal ECG.
Read the detailed description
The electrocardiogram (ECG) at presentation is a useful tool for risk prediction. Patients with ACS（Acute Coronary Syndromes） and ST-segment depression on ECG have a worse prognosis than patients with a normal ECG. ST-segment depression is not only a qualitative marker, but also a quantitative marker of risk, because the number of leads with ST-segment depression and the magnitude of ST-segment depression (either within a single lead or as sum over all leads) are indicative of the extent of ischaemia and correlate with prognosis.The presence of ST-segment depression >1 mm in >_6 leads in conjunction with ST-segment elevation in aVR and/or V1, particularly if the patient presents with haemodynamic compromise, suggests multivessel ischaemia or severe left main coronary artery stenosis. However,in patients presenting without persistent ST-segment elevation,the clinical features, treatments, and outcomes in patients with normal ECG is still unclear.
- Keywords
- Clinical Characteristics, Treatments, Outcomes, normal ECG
- 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 |
|---|---|---|
| NSTEMI Patients presenting with normal ECG | NSTEMI Patients presenting with normal ECG | |
| NSTEMI Patients presenting with isolated T wave inversion | NSTEMI Patients presenting with isolated T wave inversion | |
| NSTEMI Patients presenting with transient ST-segment elevation | NSTEMI Patients presenting with transient ST-segment elevation | |
| NSTEMI Patients presenting with resting U wave inversion | NSTEMI Patients presenting with resting U wave inversion | |
| NSTEMI Patients presenting with low QRS voltage | NSTEMI Patients presenting with low QRS voltage |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE within 2 weeks
Major Adverse Cardiovascular Events within2 weeks
Measured: within 2 weeks
MACE within 1 year
Major Adverse Cardiovascular Events in-hospital within 1 year
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yansheng Huang, Study director, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710446
- Sponsor's protocol ID
- Normal MI
- Status last verified
- Aug 2022
- First submitted
- 2 Dec 2020
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Treatments, and Outcomes of MI Patients Presenting With Normal ECG
- ClinicalTrials.gov ID
- NCT04710446
- Acronym / sponsor ID
- Normal MI
- Keywords
- Clinical Characteristics, Treatments, Outcomes, normal ECG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Jan 2021 (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 investigators aimed to analyzed data for hospitalized MI patients with normal ECG.
Detailed description
The electrocardiogram (ECG) at presentation is a useful tool for risk prediction. Patients with ACS（Acute Coronary Syndromes） and ST-segment depression on ECG have a worse prognosis than patients with a normal ECG. ST-segment depression is not only a qualitative marker, but also a quantitative marker of risk, because the number of leads with ST-segment depression and the magnitude of ST-segment depression (either within a single lead or as sum over all leads) are indicative of the extent of ischaemia and correlate with prognosis.The presence of ST-segment depression >1 mm in >_6 leads in conjunction with ST-segment elevation in aVR and/or V1, particularly if the patient presents with haemodynamic compromise, suggests multivessel ischaemia or severe left main coronary artery stenosis. However,in patients presenting without persistent ST-segment elevation,the clinical features, treatments, and outcomes in patients with normal ECG is still unclear.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NSTEMI Patients presenting with normal ECG | – | –NSTEMI Patients presenting with normal ECG |
| NSTEMI Patients presenting with isolated T wave inversion | – | –NSTEMI Patients presenting with isolated T wave inversion |
| NSTEMI Patients presenting with transient ST-segment elevation | – | –NSTEMI Patients presenting with transient ST-segment elevation |
| NSTEMI Patients presenting with resting U wave inversion | – | –NSTEMI Patients presenting with resting U wave inversion |
| NSTEMI Patients presenting with low QRS voltage | – | –NSTEMI Patients presenting with low QRS voltage |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSTEMI Patients
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
MACE within 2 weeks
Time frame: within 2 weeks
Major Adverse Cardiovascular Events within2 weeks
MACE within 1 year
Time frame: within 1 year
Major Adverse Cardiovascular Events in-hospital within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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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.
yansheng Huang study director
Henan Provincial People's Hospital
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 Elevated Myocardial Infarction and Electrocardiography, run by Henan Provincial People's 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?
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 12 Aug 2022. 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 qiongya Guo (18838067197, gqy19870203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE within 2 weeks (time frame: within 2 weeks). The study lists 2 primary outcomes in all. 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 12 Aug 2022.