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出境医 / 临床实验 / The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI

The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI

Study Description
Brief 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 when the glomerular filtration rate below a certain value.

Condition or disease
ST Elevation Myocardial Infarction

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Predictive Value of Estimated Glomerular Filtration Rate (eGFR) for Adverse Cardiovascular Events in the Hospital in Patients With ST-segment Elevation
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. major adverse cardiac events [ Time Frame: The median time of 7 days ]
    Relationship between reduced eGFR and in-hospital MACE


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   24 Years to 93 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
STEMI Patients
Criteria

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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date June 11, 2019
First Posted Date June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date October 1, 2015
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019)
major adverse cardiac events [ Time Frame: The median time of 7 days ]
Relationship between reduced eGFR and in-hospital MACE
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI
Official Title The Predictive Value of Estimated Glomerular Filtration Rate (eGFR) for Adverse Cardiovascular Events in the Hospital in Patients With ST-segment Elevation
Brief 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population STEMI Patients
Condition ST Elevation Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2019)
3
Original Actual Enrollment Same as current
Actual Study Completion Date February 28, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Years to 93 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03984071
Other Study ID Numbers 2019-06-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dongying Zhang, Chongqing Medical University
Study Sponsor Dongying Zhang
Collaborators Not Provided
Investigators Not Provided
PRS Account Chongqing Medical University
Verification Date June 2019