- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04710446
Clinical Characteristics, Treatments, and Outcomes of MI Patients Presenting With Normal ECG
August 11, 2022 updated by: Henan Provincial People's Hospital
the investigators aimed to analyzed data for hospitalized MI patients with normal ECG.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: qiongya Guo
- Phone Number: 18838067197
- Email: gqy19870203@163.com
Study Contact Backup
- Name: minghu Zhao
- Phone Number: 13603996609
- Email: 634851967@qq.com
Study Locations
-
-
Henan
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Zhengzhou, Henan, China
- Recruiting
- Henan Province People's Hospital
-
Contact:
- yansheng Huang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
NSTEMI Patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
NSTEMI Patients presenting with normal ECG
|
|
NSTEMI Patients presenting with isolated T wave inversion
|
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NSTEMI Patients presenting with transient ST-segment elevation
|
|
NSTEMI Patients presenting with resting U wave inversion
|
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NSTEMI Patients presenting with low QRS voltage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MACE within 2 weeks
Time Frame: within 2 weeks
|
Major Adverse Cardiovascular Events within2 weeks
|
within 2 weeks
|
|
MACE within 1 year
Time Frame: within 1 year
|
Major Adverse Cardiovascular Events in-hospital within 1 year
|
within 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: yansheng Huang, Henan Provincial People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
January 12, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
August 12, 2022
Last Update Submitted That Met QC Criteria
August 11, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Normal MI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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