- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984071
The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI
June 11, 2019 updated by: Dongying Zhang
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
3
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
24 years to 93 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
STEMI Patients
Description
Inclusion Criteria:
- 1.Patients with STEMI 2.Patients from whom informed consent has been properly obtained in writing prior to start of the trial
Exclusion Criteria:
- 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.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major adverse cardiac events
Time Frame: The median time of 7 days
|
Relationship between reduced eGFR and in-hospital MACE
|
The median time of 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2015
Primary Completion (Actual)
February 28, 2018
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
June 11, 2019
First Submitted That Met QC Criteria
June 11, 2019
First Posted (Actual)
June 12, 2019
Study Record Updates
Last Update Posted (Actual)
June 12, 2019
Last Update Submitted That Met QC Criteria
June 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-06-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.