ST Elevation Myocardial InfarctionNCT03984071
The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI
An observational study of ST Elevation Myocardial Infarction, run by Dongying Zhang.
Trial summary
Estimated glomerular filtration rate(eGFR) is significantly reduced in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study is to research that the incidence of adverse cardiovascular events (MACE) in patients with ST-segment elevation myocardial infarction is significantly higher… Read more about this study
- Who is it for?
- Ages 24 to 93 yearsHealthy volunteers can take part
- Conditions the study is for
- ST Elevation Myocardial Infarction
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 28 Feb 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 24 to 93 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: STEMI Patients
Who may be able to join
- 1.Patients with STEMI 2.Patients from whom informed consent has been properly obtained in writing prior to start of the trial
Who cannot join
- 1.Patients with previous myocardial infarction, congenital heart disease 2.Patients with liver disease, and renal failure 3.Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.
About this study
Official title: The Predictive Value of Estimated Glomerular Filtration Rate (eGFR) for Adverse Cardiovascular Events in the Hospital in Patients With ST-segment Elevation
Estimated glomerular filtration rate(eGFR) is significantly reduced in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study is to research that the incidence of adverse cardiovascular events (MACE) in patients with ST-segment elevation myocardial infarction is significantly higher when the glomerular filtration rate below a certain value.
Read the detailed description
The investigators retrospectively analyzed the clinical data of 1157 patients with ST-segment elevation myocardial infarction. In-hospital adverse cardiovascular events (MACE) was defined as: cardiac arrest, cardiac rupture, malignant arrhythmia, and cardiac death. All the patients were divided into 3 groups according to the patient's estimated glomerular filtration rate(eGFR) (eGFR≥90ml/min/1.73m2; 90ml/min/1.73m2>eGFR≥60ml/min/1.73m2; eGFR<60ml/min /1.73m2). COX regression analysis and K-M survival curves are used to calculate the correlation between eGFR and in-hospital MACE.
- Conditions
- ST Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events
Relationship between reduced eGFR and in-hospital MACE
Measured: The median time of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Oct 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongying Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongying Zhang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984071
- Sponsor's protocol ID
- 2019-06-11
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Estimated Glomerular Filtration Rate (eGFR) for Adverse Cardiovascular Events in the Hospital in Patients With ST-segment Elevation
- ClinicalTrials.gov ID
- NCT03984071
- Acronym / sponsor ID
- 2019-06-11
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Dongying ZhangUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 12 Jun 2019 (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.
Estimated glomerular filtration rate(eGFR) is significantly reduced in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study is to research that the incidence of adverse cardiovascular events (MACE) in patients with ST-segment elevation myocardial infarction is significantly higher when the glomerular filtration rate below a certain value.
Detailed description
The investigators retrospectively analyzed the clinical data of 1157 patients with ST-segment elevation myocardial infarction. In-hospital adverse cardiovascular events (MACE) was defined as: cardiac arrest, cardiac rupture, malignant arrhythmia, and cardiac death. All the patients were divided into 3 groups according to the patient's estimated glomerular filtration rate(eGFR) (eGFR≥90ml/min/1.73m2; 90ml/min/1.73m2>eGFR≥60ml/min/1.73m2; eGFR<60ml/min /1.73m2). COX regression analysis and K-M survival curves are used to calculate the correlation between eGFR and in-hospital MACE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 93 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI Patients
Key inclusion criteria (1 listed)
- 1.Patients with STEMI 2.Patients from whom informed consent has been properly obtained in writing prior to start of the trial
Key exclusion criteria (1 listed)
- 1.Patients with previous myocardial infarction, congenital heart disease 2.Patients with liver disease, and renal failure 3.Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.
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
major adverse cardiac events
Time frame: The median time of 7 days
Relationship between reduced eGFR and in-hospital MACE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Dongying Zhang.
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 1 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: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac events (time frame: The median time of 7 days). 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 Jun 2019.