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The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740776
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dongying Zhang, Chongqing Medical University

Tracking Information
First Submitted Date November 7, 2018
First Posted Date November 14, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date October 1, 2015
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2018)
major adverse cardiac events [ Time Frame: The median time of 7 days ]
the relationship between reduced eosinophils percentage 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 Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI
Official Title The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in Patients With ST-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
Brief Summary Eosinophils (EOS) in peripheral blood are significantly decreased in ST-segment elevation myocardial infarction (STEMI) and the reduced EOS indicates severe myocardial damage. Whether EOS is a good predictor for in-hospital major adverse cardiac events (MACEs) of patients with ST-segment elevation myocardial infarction remains unknown. The aims of this study was to evaluate prognostic role of EOS for in-hospital MACEs in STEMI patients who have undergone primary percutaneous coronary intervention (PCI)
Detailed Description The investigators retrospectively analyzed the clinical data of 518 patients with STEMI after PCI. MACEs were defined as cardiac arrest, cardiac rapture, malignant arrhythmia and cardiac death. The receiver operating characteristic (ROC) curves were used to demonstrate the prognostic value of EOS% in in-hospital MACEs. All patients were divided into 2 groups according to the best cut-off EOS% value, including reduced EOS% group and control group. Cox regression analyses and KM survival curve were used to calculate the correlated between EOS with in-hospital MACEs.
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: November 13, 2018)
2
Original Actual Enrollment Same as current
Actual Study Completion Date November 1, 2018
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with STEMI who underwent PCI within 12 hours from symptom onset
  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 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03740776
Other Study ID Numbers 2018-35
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
Plan to Share IPD: Undecided
Responsible Party Dongying Zhang, Chongqing Medical University
Study Sponsor Dongying Zhang
Collaborators Not Provided
Investigators Not Provided
PRS Account Chongqing Medical University
Verification Date November 2018